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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Maithri Drugs

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    Maithri Drugs
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    Country
    India
    Address
    Address
    Dwaraka Signature, Plot No 14D/1, 2nd Floor, Sy. No. 74 & 75, Jaihind Enclave, Madhapur, Hyderabad. 500 081
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    Telephone
    +91-40-69076600
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    enquiries@pharmacompass.com
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    https://maithridrugs.com/
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      Carbimazole

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      USDMF

      Found USDMF

      35808
      Active
      CARBIMAZOLE
      2021-03-29
      CEP/COS

      Found CEP/COS

      R0-CEP 2018-103 - Rev 01
      Valid
      Carbimazole
      2023-07-20
      Japanese DMF

      Close JDMF

      Written Confirmation

      Caution WC

      Indian CDSCO WC-0407
      Expired
      Carbimazole EP
      2020-09-09
      Application Number
      35808
      R0-CEP 2018-103 - Rev 01
      Indian CDSCO WC-0407
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Expired
      2023-06-28
      Filing Details
      CARBIMAZOLE
      Carbimazole
      Carbimazole EP
      Issue/Submission Date
      2021-03-29
      2023-07-20
      2020-09-09
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        Chlorthalidone

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        USDMF

        Found USDMF

        32641
        Active
        CHLORTHALIDONE USP
        2018-03-30
        CEP/COS

        Found CEP/COS

        R0-CEP 2018-186 - Rev 01
        Valid
        Chlortalidone
        2023-08-29
        Japanese DMF

        Close JDMF

        Written Confirmation

        Caution WC

        Indian CDSCO WC-0407
        Expired
        Chlorthalidone USP/EP
        2020-09-09
        Application Number
        32641
        R0-CEP 2018-186 - Rev 01
        Indian CDSCO WC-0407
        Status
        Active
        Fees Unpaid
        Reviewed
        Valid
         
        Expired
        2023-06-28
        Filing Details
        CHLORTHALIDONE USP
        Chlortalidone
        Chlorthalidone USP/EP
        Issue/Submission Date
        2018-03-30
        2023-08-29
        2020-09-09
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          Mesalazine

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          USDMF

          Found USDMF

          31570
          Active
          MESALAMINE USP
          2017-03-31
          CEP/COS

          Found CEP/COS

          R1-CEP 2017-116 - Rev 00
          Valid
          Mesalazine
          2023-04-13
          Japanese DMF

          Close JDMF

          Written Confirmation

          Caution WC

          Indian CDSCO WC-0407
          Expired
          Mesalamine USP/EP
          2020-09-09
          Application Number
          31570
          R1-CEP 2017-116 - Rev 00
          Indian CDSCO WC-0407
          Status
          Active
          Fees Unpaid
          N/A
          Valid
           
          Expired
          2023-06-28
          Filing Details
          MESALAMINE USP
          Mesalazine
          Mesalamine USP/EP
          Issue/Submission Date
          2017-03-31
          2023-04-13
          2020-09-09
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            Mirtazapine

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            USDMF

            Found USDMF

            31322
            Active
            MIRTAZAPINE USP [ROUTE CODE - MZ)
            2017-01-19
            CEP/COS

            Found CEP/COS

            R1-CEP 2017-010 - Rev 00
            Valid
            Mirtazapine
            2023-03-13
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0407
            Expired
            Mirtazapine EP/USP
            2020-09-09
            Application Number
            31322
            R1-CEP 2017-010 - Rev 00
            Indian CDSCO WC-0407
            Status
            Active
            Fees Unpaid
            N/A
            Valid
             
            Expired
            2023-06-28
            Filing Details
            MIRTAZAPINE USP [ROUTE CODE - MZ)
            Mirtazapine
            Mirtazapine EP/USP
            Issue/Submission Date
            2017-01-19
            2023-03-13
            2020-09-09
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              Nitrofurantoin

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              USDMF

              Found USDMF

              33877
              Active
              NITROFURANTOIN HYDROUS USP
              2019-05-31
              CEP/COS

              Found CEP/COS

              R0-CEP 2022-074 - Rev 00
              Valid
              Nitrofurantoin, Macrocrystals
              2022-12-12
              Japanese DMF

              Close JDMF

              Written Confirmation

              Caution WC

              Indian CDSCO WC-0407a4
              Expired
              Nitrofurantoin Hydrous USP/Anhydrou...
              2020-10-20
              Application Number
              33877
              R0-CEP 2022-074 - Rev 00
              Indian CDSCO WC-0407a4
              Status
              Active
              Fees Unpaid
              Reviewed
              Valid
               
              Expired
              2023-06-28
              Filing Details
              NITROFURANTOIN HYDROUS USP
              Nitrofurantoin, Macrocrystals
              Nitrofurantoin Hydrous USP/Anhydrou...
              Issue/Submission Date
              2019-05-31
              2022-12-12
              2020-10-20
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                Brimonidine Tartrate

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                USDMF

                Found USDMF

                36595
                Active
                BRIMONIDINE TARTRATE USP
                2021-12-09
                CEP/COS

                Found CEP/COS

                R0-CEP 2021-507 - Rev 00
                Valid
                Brimonidine tartrate
                2023-07-04
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                36595
                R0-CEP 2021-507 - Rev 00
                Status
                Active
                Fees Unpaid
                N/A
                Valid
                 
                Filing Details
                BRIMONIDINE TARTRATE USP
                Brimonidine tartrate
                Issue/Submission Date
                2021-12-09
                2023-07-04
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                  Brivaracetam

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                  USDMF

                  Found USDMF

                  33709
                  Active
                  BRIVARACETAM
                  2019-03-29
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Found WC

                  Indian CDSCO WC-0455
                  Valid
                  Brivaracetam IH
                  2022-11-18
                  Application Number
                  33709
                  Indian CDSCO WC-0455
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                   
                  Valid
                  2025-09-30
                  Filing Details
                  BRIVARACETAM
                  Brivaracetam IH
                  Issue/Submission Date
                  2019-03-29
                  2022-11-18
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                    Carbidopa

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                    USDMF

                    Found USDMF

                    35521
                    Active
                    CARBIDOPA USP
                    2020-12-31
                    CEP/COS

                    Found CEP/COS

                    R0-CEP 2020-143 - Rev 00
                    Valid
                    Carbidopa
                    2021-06-11
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    35521
                    R0-CEP 2020-143 - Rev 00
                    Status
                    Active
                    Fees Unpaid
                    N/A
                    Valid
                     
                    Filing Details
                    CARBIDOPA USP
                    Carbidopa
                    Issue/Submission Date
                    2020-12-31
                    2021-06-11
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                      Chlorpromazine Hydrochloride

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                      USDMF

                      Found USDMF

                      33353
                      Active
                      CHLORPROMAZINE HYDROCHLORIDE USP
                      2018-11-29
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Found WC

                      Indian CDSCO WC-0455
                      Valid
                      Chlorpromazine Hydrochloride IH/USP...
                      2022-11-18
                      Application Number
                      33353
                      Indian CDSCO WC-0455
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
                      Valid
                      2025-09-30
                      Filing Details
                      CHLORPROMAZINE HYDROCHLORIDE USP
                      Chlorpromazine Hydrochloride IH/USP...
                      Issue/Submission Date
                      2018-11-29
                      2022-11-18
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                        Eliglustat

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                        USDMF

                        Found USDMF

                        32612
                        Active
                        ELIGLUSTAT TARTRATE (PREMIX)
                        2018-03-28
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Found WC

                        Indian CDSCO WC-0455
                        Valid
                        Eliglustat Tartrate IH / Premix IH
                        2022-11-18
                        Application Number
                        32612
                        Indian CDSCO WC-0455
                        Status
                        Active
                        Fees Unpaid
                        Reviewed
                         
                        Valid
                        2025-09-30
                        Filing Details
                        ELIGLUSTAT TARTRATE (PREMIX)
                        Eliglustat Tartrate IH / Premix IH
                        Issue/Submission Date
                        2018-03-28
                        2022-11-18
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                          Esketamine Hydrochloride

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                          USDMF

                          Found USDMF

                          37012
                          Active
                          ESKETAMINE HYDROCHLORIDE
                          2022-08-04
                          CEP/COS

                          Found CEP/COS

                          CEP 2022-319 - Rev 00
                          Valid
                          Esketamine hydrochloride
                          2024-05-03
                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          37012
                          CEP 2022-319 - Rev 00
                          Status
                          Active
                          Fees Unpaid
                          N/A
                          Valid
                           
                          Filing Details
                          ESKETAMINE HYDROCHLORIDE
                          Esketamine hydrochloride
                          Issue/Submission Date
                          2022-08-04
                          2024-05-03
                          ASK
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                            Etilevodopa

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                            USDMF

                            Found USDMF

                            35312
                            Active
                            LEVODOPA USP
                            2020-10-17
                            CEP/COS

                            Found CEP/COS

                            R0-CEP 2020-161 - Rev 00
                            Valid
                            Levodopa
                            2022-03-14
                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            35312
                            R0-CEP 2020-161 - Rev 00
                            Status
                            Active
                            Fees Unpaid
                            N/A
                            Valid
                             
                            Filing Details
                            LEVODOPA USP
                            Levodopa
                            Issue/Submission Date
                            2020-10-17
                            2022-03-14
                            ASK
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                              Fesoterodine

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                              USDMF

                              Found USDMF

                              33230
                              Active
                              FESOTERODINE FUMARATE
                              2018-09-29
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Found WC

                              Indian CDSCO WC-0455
                              Valid
                              Fesoterodine Fumarate IH
                              2022-11-18
                              Application Number
                              33230
                              Indian CDSCO WC-0455
                              Status
                              Active
                              Fees Unpaid
                              Reviewed
                               
                              Valid
                              2025-09-30
                              Filing Details
                              FESOTERODINE FUMARATE
                              Fesoterodine Fumarate IH
                              Issue/Submission Date
                              2018-09-29
                              2022-11-18
                              ASK
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                                Fluocytosine

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                                USDMF

                                Found USDMF

                                31959
                                Active
                                FLUCYTOSINE USP
                                2017-08-30
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Found WC

                                Indian CDSCO WC-0455
                                Valid
                                Flucytosine USP/EP
                                2022-11-18
                                Application Number
                                31959
                                Indian CDSCO WC-0455
                                Status
                                Active
                                Fees Unpaid
                                Reviewed
                                 
                                Valid
                                2025-09-30
                                Filing Details
                                FLUCYTOSINE USP
                                Flucytosine USP/EP
                                Issue/Submission Date
                                2017-08-30
                                2022-11-18
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                                  Foscarnet Sodium

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                                  USDMF

                                  Found USDMF

                                  34968
                                  Active
                                  FOSCARNET SODIUM USP
                                  2020-07-04
                                  CEP/COS

                                  Found CEP/COS

                                  R0-CEP 2020-218 - Rev 00
                                  Valid
                                  Foscarnet sodium hexahydrate
                                  2022-05-19
                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  34968
                                  R0-CEP 2020-218 - Rev 00
                                  Status
                                  Active
                                  Fees Unpaid
                                  N/A
                                  Valid
                                   
                                  Filing Details
                                  FOSCARNET SODIUM USP
                                  Foscarnet sodium hexahydrate
                                  Issue/Submission Date
                                  2020-07-04
                                  2022-05-19
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                                    Ivabradine Hydrochloride

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                                    USDMF

                                    Found USDMF

                                    33246
                                    Active
                                    IVABRADINE HYDROCHLORIDE HEMIPENTAH...
                                    2018-10-30
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Found WC

                                    Indian CDSCO WC-0455
                                    Valid
                                    Ivabradine Hydrochloride IH
                                    2022-11-18
                                    Application Number
                                    33246
                                    Indian CDSCO WC-0455
                                    Status
                                    Active
                                    Fees Unpaid
                                    Reviewed
                                     
                                    Valid
                                    2025-09-30
                                    Filing Details
                                    IVABRADINE HYDROCHLORIDE HEMIPENTAH...
                                    Ivabradine Hydrochloride IH
                                    Issue/Submission Date
                                    2018-10-30
                                    2022-11-18
                                    ASK
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                                      Ketamine Hydrochloride

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                                      USDMF

                                      Found USDMF

                                      37014
                                      Active
                                      KETAMINE HYDROCHLORIDE USP
                                      2022-03-29
                                      CEP/COS

                                      Found CEP/COS

                                      CEP 2022-157 - Rev 00
                                      Valid
                                      Ketamine hydrochloride
                                      2024-03-04
                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      37014
                                      CEP 2022-157 - Rev 00
                                      Status
                                      Active
                                      Fees Unpaid
                                      N/A
                                      Valid
                                       
                                      Filing Details
                                      KETAMINE HYDROCHLORIDE USP
                                      Ketamine hydrochloride
                                      Issue/Submission Date
                                      2022-03-29
                                      2024-03-04
                                      ASK
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                                        Methimazole

                                        PDF Supplier PDF
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                                        USDMF

                                        Found USDMF

                                        36643
                                        Active
                                        METHIMAZOLE USP
                                        2021-12-29
                                        CEP/COS

                                        Found CEP/COS

                                        CEP 2022-029 - Rev 00
                                        Valid
                                        Thiamazole
                                        2023-09-28
                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        36643
                                        CEP 2022-029 - Rev 00
                                        Status
                                        Active
                                        Fees Unpaid
                                        Reviewed
                                        Valid
                                         
                                        Filing Details
                                        METHIMAZOLE USP
                                        Thiamazole
                                        Issue/Submission Date
                                        2021-12-29
                                        2023-09-28
                                        ASK
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                                          Mirtazapine

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                                          USDMF

                                          Found USDMF

                                          37013
                                          Active
                                          MIRTAZAPINE ANHYDROUS USP
                                          2022-03-30
                                          CEP/COS

                                          Found CEP/COS

                                          CEP 2018-225 - Rev 01
                                          Valid
                                          Mirtazapine, Route code "ZA"
                                          2024-04-10
                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          37013
                                          CEP 2018-225 - Rev 01
                                          Status
                                          Active
                                          Fees Unpaid
                                          N/A
                                          Valid
                                           
                                          Filing Details
                                          MIRTAZAPINE ANHYDROUS USP
                                          Mirtazapine, Route code "ZA"
                                          Issue/Submission Date
                                          2022-03-30
                                          2024-04-10
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                                            Nitrofurantoin

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                                            USDMF

                                            Found USDMF

                                            34179
                                            Active
                                            NITROFURANTOIN ANHYDROUS USP
                                            2019-09-30
                                            CEP/COS

                                            Found CEP/COS

                                            CEP 2019-262 - Rev 01
                                            Valid
                                            Nitrofurantoin
                                            2024-05-02
                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            34179
                                            CEP 2019-262 - Rev 01
                                            Status
                                            Active
                                            Fees Unpaid
                                            N/A
                                            Valid
                                             
                                            Filing Details
                                            NITROFURANTOIN ANHYDROUS USP
                                            Nitrofurantoin
                                            Issue/Submission Date
                                            2019-09-30
                                            2024-05-02
                                            ASK
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                                              Pyridostigmine

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                                              USDMF

                                              Found USDMF

                                              35024
                                              Active
                                              PYRIDOSTIGMINE BROMIDE USP
                                              2020-08-15
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Found WC

                                              Indian CDSCO WC-0455
                                              Valid
                                              Pyridostigmine Bromide USP/EP
                                              2022-11-18
                                              Application Number
                                              35024
                                              Indian CDSCO WC-0455
                                              Status
                                              Active
                                              Fees Unpaid
                                              Reviewed
                                               
                                              Valid
                                              2025-09-30
                                              Filing Details
                                              PYRIDOSTIGMINE BROMIDE USP
                                              Pyridostigmine Bromide USP/EP
                                              Issue/Submission Date
                                              2020-08-15
                                              2022-11-18
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                                                Valganciclovir Hydrochloride

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                                                USDMF

                                                Found USDMF

                                                34617
                                                Active
                                                VALGANCICLOVIR HYDROCHLORIDE USP
                                                2020-02-29
                                                CEP/COS

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                                                Japanese DMF

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                                                Written Confirmation

                                                Found WC

                                                Indian CDSCO WC-0455
                                                Valid
                                                Valganciclovir Hydrochloride USP
                                                2022-11-18
                                                Application Number
                                                34617
                                                Indian CDSCO WC-0455
                                                Status
                                                Active
                                                Fees Unpaid
                                                Reviewed
                                                 
                                                Valid
                                                2025-09-30
                                                Filing Details
                                                VALGANCICLOVIR HYDROCHLORIDE USP
                                                Valganciclovir Hydrochloride USP
                                                Issue/Submission Date
                                                2020-02-29
                                                2022-11-18
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                                                  Dapoxetine Hydrochloride

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                                                  USDMF

                                                  Found USDMF

                                                  34632
                                                  Active
                                                  DAPOXETINE HYDROCHLORIDE
                                                  2020-02-28
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Caution WC

                                                  Indian CDSCO WC-0407
                                                  Expired
                                                  Dapoxetine Hydrochloride IH
                                                  2020-09-09
                                                  Application Number
                                                  34632
                                                  Indian CDSCO WC-0407
                                                  Status
                                                  Active
                                                  Fees Unpaid
                                                  N/A
                                                   
                                                  Expired
                                                  2023-06-28
                                                  Filing Details
                                                  DAPOXETINE HYDROCHLORIDE
                                                  Dapoxetine Hydrochloride IH
                                                  Issue/Submission Date
                                                  2020-02-28
                                                  2020-09-09
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                                                    Divalproex Sodium

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                                                    USDMF

                                                    Found USDMF

                                                    34440
                                                    Active
                                                    DIVALPROEX SODIUM USP
                                                    2019-12-21
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Caution WC

                                                    Indian CDSCO WC-0407a4
                                                    Expired
                                                    Divalproex Sodium USP
                                                    2020-10-20
                                                    Application Number
                                                    34440
                                                    Indian CDSCO WC-0407a4
                                                    Status
                                                    Active
                                                    Fees Unpaid
                                                    N/A
                                                     
                                                    Expired
                                                    2023-06-28
                                                    Filing Details
                                                    DIVALPROEX SODIUM USP
                                                    Divalproex Sodium USP
                                                    Issue/Submission Date
                                                    2019-12-21
                                                    2020-10-20
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                                                      Docosanol

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                                                      USDMF

                                                      Found USDMF

                                                      33229
                                                      Active
                                                      DOCOSANOL
                                                      2018-10-17
                                                      CEP/COS

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                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Caution WC

                                                      Indian CDSCO WC-0407
                                                      Expired
                                                      Docosanol IH
                                                      2020-09-09
                                                      Application Number
                                                      33229
                                                      Indian CDSCO WC-0407
                                                      Status
                                                      Active
                                                      Fees Unpaid
                                                      Reviewed
                                                       
                                                      Expired
                                                      2023-06-28
                                                      Filing Details
                                                      DOCOSANOL
                                                      Docosanol IH
                                                      Issue/Submission Date
                                                      2018-10-17
                                                      2020-09-09
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                                                        Efinaconazole

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                                                        USDMF

                                                        Found USDMF

                                                        30420
                                                        Active
                                                        EFINACONAZOLE [ROUTE CODE 'EC']
                                                        2016-03-30
                                                        CEP/COS

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                                                        Japanese DMF

                                                        Close JDMF

                                                        Written Confirmation

                                                        Caution WC

                                                        Indian CDSCO WC-0407
                                                        Expired
                                                        Efinaconazole (IH)
                                                        2020-09-09
                                                        Application Number
                                                        30420
                                                        Indian CDSCO WC-0407
                                                        Status
                                                        Active
                                                        Fees Unpaid
                                                        Reviewed
                                                         
                                                        Expired
                                                        2023-06-28
                                                        Filing Details
                                                        EFINACONAZOLE [ROUTE CODE 'EC']
                                                        Efinaconazole (IH)
                                                        Issue/Submission Date
                                                        2016-03-30
                                                        2020-09-09
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                                                          Lomitapide

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                                                          USDMF

                                                          Found USDMF

                                                          31454
                                                          Active
                                                          LOMITAPIDE MESYLATE (FORM-M)
                                                          2017-02-22
                                                          CEP/COS

                                                          Close CEP/COS

                                                          Japanese DMF

                                                          Close JDMF

                                                          Written Confirmation

                                                          Caution WC

                                                          Indian CDSCO WC-0407
                                                          Expired
                                                          Lomitapide Mesylate IH
                                                          2020-09-09
                                                          Application Number
                                                          31454
                                                          Indian CDSCO WC-0407
                                                          Status
                                                          Active
                                                          Fees Unpaid
                                                          N/A
                                                           
                                                          Expired
                                                          2023-06-28
                                                          Filing Details
                                                          LOMITAPIDE MESYLATE (FORM-M)
                                                          Lomitapide Mesylate IH
                                                          Issue/Submission Date
                                                          2017-02-22
                                                          2020-09-09
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                                                            Luliconazole

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                                                            USDMF

                                                            Found USDMF

                                                            32935
                                                            Active
                                                            LULICONAZOLE
                                                            2018-07-06
                                                            CEP/COS

                                                            Close CEP/COS

                                                            Japanese DMF

                                                            Close JDMF

                                                            Written Confirmation

                                                            Caution WC

                                                            Indian CDSCO WC-0407
                                                            Expired
                                                            Luliconazole IH
                                                            2020-09-09
                                                            Application Number
                                                            32935
                                                            Indian CDSCO WC-0407
                                                            Status
                                                            Active
                                                            Fees Unpaid
                                                            N/A
                                                             
                                                            Expired
                                                            2023-06-28
                                                            Filing Details
                                                            LULICONAZOLE
                                                            Luliconazole IH
                                                            Issue/Submission Date
                                                            2018-07-06
                                                            2020-09-09
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                                                              Lumacaftor

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                                                              USDMF

                                                              Found USDMF

                                                              33887
                                                              Active
                                                              LUMACAFTOR
                                                              2019-06-12
                                                              CEP/COS

                                                              Close CEP/COS

                                                              Japanese DMF

                                                              Close JDMF

                                                              Written Confirmation

                                                              Caution WC

                                                              Indian CDSCO WC-0407a4
                                                              Expired
                                                              Lumacaftor IH
                                                              2020-10-20
                                                              Application Number
                                                              33887
                                                              Indian CDSCO WC-0407a4
                                                              Status
                                                              Active
                                                              Fees Unpaid
                                                              N/A
                                                               
                                                              Expired
                                                              2023-06-28
                                                              Filing Details
                                                              LUMACAFTOR
                                                              Lumacaftor IH
                                                              Issue/Submission Date
                                                              2019-06-12
                                                              2020-10-20
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                                                                Selexipag

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                                                                USDMF

                                                                Found USDMF

                                                                32123
                                                                Active
                                                                SELEXIPAG (FORM-P)
                                                                2017-10-13
                                                                CEP/COS

                                                                Close CEP/COS

                                                                Japanese DMF

                                                                Close JDMF

                                                                Written Confirmation

                                                                Caution WC

                                                                Indian CDSCO WC-0407
                                                                Expired
                                                                Selexipag IH
                                                                2020-09-09
                                                                Application Number
                                                                32123
                                                                Indian CDSCO WC-0407
                                                                Status
                                                                Active
                                                                Fees Unpaid
                                                                Reviewed
                                                                 
                                                                Expired
                                                                2023-06-28
                                                                Filing Details
                                                                SELEXIPAG (FORM-P)
                                                                Selexipag IH
                                                                Issue/Submission Date
                                                                2017-10-13
                                                                2020-09-09
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                                                                  Tigecycline

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                                                                  USDMF

                                                                  Found USDMF

                                                                  30422
                                                                  Active
                                                                  TIGECYCLINE USP (FORM-II) [ROUTE CO...
                                                                  2016-03-31
                                                                  CEP/COS

                                                                  Close CEP/COS

                                                                  Japanese DMF

                                                                  Close JDMF

                                                                  Written Confirmation

                                                                  Caution WC

                                                                  Indian CDSCO WC-0407
                                                                  Expired
                                                                  Tigecycline USP
                                                                  2020-09-09
                                                                  Application Number
                                                                  30422
                                                                  Indian CDSCO WC-0407
                                                                  Status
                                                                  Active
                                                                  Fees Unpaid
                                                                  Reviewed
                                                                   
                                                                  Expired
                                                                  2023-06-28
                                                                  Filing Details
                                                                  TIGECYCLINE USP (FORM-II) [ROUTE CO...
                                                                  Tigecycline USP
                                                                  Issue/Submission Date
                                                                  2016-03-31
                                                                  2020-09-09
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                                                                    Varenicline Tartrate

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                                                                    USDMF

                                                                    Found USDMF

                                                                    34174
                                                                    Active
                                                                    VARENICLINE TARTRATE
                                                                    2019-09-30
                                                                    CEP/COS

                                                                    Close CEP/COS

                                                                    Japanese DMF

                                                                    Close JDMF

                                                                    Written Confirmation

                                                                    Caution WC

                                                                    Indian CDSCO WC-0407a4
                                                                    Expired
                                                                    Varenicline Tartrate IH
                                                                    2020-10-20
                                                                    Application Number
                                                                    34174
                                                                    Indian CDSCO WC-0407a4
                                                                    Status
                                                                    Active
                                                                    Fees Unpaid
                                                                    Reviewed
                                                                     
                                                                    Expired
                                                                    2023-06-28
                                                                    Filing Details
                                                                    VARENICLINE TARTRATE
                                                                    Varenicline Tartrate IH
                                                                    Issue/Submission Date
                                                                    2019-09-30
                                                                    2020-10-20
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                                                                      Zonisamide

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                                                                      USDMF

                                                                      Found USDMF

                                                                      31009
                                                                      Active
                                                                      ZONISAMIDE USP
                                                                      2016-09-30
                                                                      CEP/COS

                                                                      Close CEP/COS

                                                                      Japanese DMF

                                                                      Close JDMF

                                                                      Written Confirmation

                                                                      Caution WC

                                                                      Indian CDSCO WC-0407
                                                                      Expired
                                                                      Zonisamide (IH)
                                                                      2020-09-09
                                                                      Application Number
                                                                      31009
                                                                      Indian CDSCO WC-0407
                                                                      Status
                                                                      Active
                                                                      Fees Unpaid
                                                                      Reviewed
                                                                       
                                                                      Expired
                                                                      2023-06-28
                                                                      Filing Details
                                                                      ZONISAMIDE USP
                                                                      Zonisamide (IH)
                                                                      Issue/Submission Date
                                                                      2016-09-30
                                                                      2020-09-09
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                                                                        Besifloxacin Hydrochloride

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                                                                        USDMF

                                                                        Found USDMF

                                                                        35809
                                                                        Active
                                                                        BESIFLOXACIN HYDROCHLORIDE
                                                                        2021-03-29
                                                                        CEP/COS

                                                                        Close CEP/COS

                                                                        Japanese DMF

                                                                        Close JDMF

                                                                        Written Confirmation

                                                                        Close WC

                                                                        Application Number
                                                                        35809
                                                                        Status
                                                                        Active
                                                                        Fees Unpaid
                                                                        N/A
                                                                         
                                                                        Filing Details
                                                                        BESIFLOXACIN HYDROCHLORIDE
                                                                        Issue/Submission Date
                                                                        2021-03-29
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                                                                          Cysteamine Bitartrate

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                                                                          USDMF

                                                                          Found USDMF

                                                                          35758
                                                                          Active
                                                                          CYSTEAMINE BITARTRATE (MONOHYDRATE)
                                                                          2021-03-29
                                                                          CEP/COS

                                                                          Close CEP/COS

                                                                          Japanese DMF

                                                                          Close JDMF

                                                                          Written Confirmation

                                                                          Close WC

                                                                          Application Number
                                                                          35758
                                                                          Status
                                                                          Active
                                                                          Fees Unpaid
                                                                          N/A
                                                                           
                                                                          Filing Details
                                                                          CYSTEAMINE BITARTRATE (MONOHYDRATE)
                                                                          Issue/Submission Date
                                                                          2021-03-29
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                                                                            Deutetrabenazine

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                                                                            USDMF

                                                                            Found USDMF

                                                                            35158
                                                                            Active
                                                                            DEUTETRABENAZINE
                                                                            2020-08-31
                                                                            CEP/COS

                                                                            Close CEP/COS

                                                                            Japanese DMF

                                                                            Close JDMF

                                                                            Written Confirmation

                                                                            Close WC

                                                                            Application Number
                                                                            35158
                                                                            Status
                                                                            Active
                                                                            Fees Unpaid
                                                                            N/A
                                                                             
                                                                            Filing Details
                                                                            DEUTETRABENAZINE
                                                                            Issue/Submission Date
                                                                            2020-08-31
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                                                                              Eliglustat

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                                                                              USDMF

                                                                              Found USDMF

                                                                              32653
                                                                              Active
                                                                              ELIGLUSTAT TARTRATE
                                                                              2018-03-27
                                                                              CEP/COS

                                                                              Close CEP/COS

                                                                              Japanese DMF

                                                                              Close JDMF

                                                                              Written Confirmation

                                                                              Close WC

                                                                              Application Number
                                                                              32653
                                                                              Status
                                                                              Active
                                                                              Fees Unpaid
                                                                              N/A
                                                                               
                                                                              Filing Details
                                                                              ELIGLUSTAT TARTRATE
                                                                              Issue/Submission Date
                                                                              2018-03-27
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                                                                                Fenfluramine Hydrochloride

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                                                                                USDMF

                                                                                Found USDMF

                                                                                34897
                                                                                Active
                                                                                FENFLURAMINE HYDROCHLORIDE
                                                                                2020-05-30
                                                                                CEP/COS

                                                                                Close CEP/COS

                                                                                Japanese DMF

                                                                                Close JDMF

                                                                                Written Confirmation

                                                                                Close WC

                                                                                Application Number
                                                                                34897
                                                                                Status
                                                                                Active
                                                                                Fees Unpaid
                                                                                Reviewed
                                                                                 
                                                                                Filing Details
                                                                                FENFLURAMINE HYDROCHLORIDE
                                                                                Issue/Submission Date
                                                                                2020-05-30
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                                                                                  Lercanidipine

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                                                                                  USDMF

                                                                                  Found USDMF

                                                                                  35507
                                                                                  Active
                                                                                  LERCANIDIPINE HYDROCHLORIDE (AMORPH...
                                                                                  2020-12-30
                                                                                  CEP/COS

                                                                                  Close CEP/COS

                                                                                  Japanese DMF

                                                                                  Close JDMF

                                                                                  Written Confirmation

                                                                                  Close WC

                                                                                  Application Number
                                                                                  35507
                                                                                  Status
                                                                                  Active
                                                                                  Fees Unpaid
                                                                                  N/A
                                                                                   
                                                                                  Filing Details
                                                                                  LERCANIDIPINE HYDROCHLORIDE (AMORPH...
                                                                                  Issue/Submission Date
                                                                                  2020-12-30
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                                                                                    Lercanidipine

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                                                                                    USDMF

                                                                                    Found USDMF

                                                                                    35609
                                                                                    Active
                                                                                    LERCANIDIPINE HYDROCHLORIDE (FORM-I...
                                                                                    2021-01-30
                                                                                    CEP/COS

                                                                                    Close CEP/COS

                                                                                    Japanese DMF

                                                                                    Close JDMF

                                                                                    Written Confirmation

                                                                                    Close WC

                                                                                    Application Number
                                                                                    35609
                                                                                    Status
                                                                                    Active
                                                                                    Fees Unpaid
                                                                                    N/A
                                                                                     
                                                                                    Filing Details
                                                                                    LERCANIDIPINE HYDROCHLORIDE (FORM-I...
                                                                                    Issue/Submission Date
                                                                                    2021-01-30
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                                                                                      Netarsudil Mesylate

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                                                                                      USDMF

                                                                                      Found USDMF

                                                                                      35819
                                                                                      Active
                                                                                      NETARSUDIL DIMESYLATE
                                                                                      2021-03-31
                                                                                      CEP/COS

                                                                                      Close CEP/COS

                                                                                      Japanese DMF

                                                                                      Close JDMF

                                                                                      Written Confirmation

                                                                                      Close WC

                                                                                      Application Number
                                                                                      35819
                                                                                      Status
                                                                                      Active
                                                                                      Fees Unpaid
                                                                                      N/A
                                                                                       
                                                                                      Filing Details
                                                                                      NETARSUDIL DIMESYLATE
                                                                                      Issue/Submission Date
                                                                                      2021-03-31
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                                                                                        Nitrofurantoin

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                                                                                        USDMF

                                                                                        Found USDMF

                                                                                        34631
                                                                                        Active
                                                                                        NITROFURANTOIN ANHYDROUS USP (MACRO...
                                                                                        2020-03-06
                                                                                        CEP/COS

                                                                                        Close CEP/COS

                                                                                        Japanese DMF

                                                                                        Close JDMF

                                                                                        Written Confirmation

                                                                                        Close WC

                                                                                        Application Number
                                                                                        34631
                                                                                        Status
                                                                                        Active
                                                                                        Fees Unpaid
                                                                                        N/A
                                                                                         
                                                                                        Filing Details
                                                                                        NITROFURANTOIN ANHYDROUS USP (MACRO...
                                                                                        Issue/Submission Date
                                                                                        2020-03-06
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                                                                                          Ozanimod

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                                                                                          USDMF

                                                                                          Found USDMF

                                                                                          37015
                                                                                          Active
                                                                                          OZANIMOD HYDROCHLORIDE
                                                                                          2022-03-31
                                                                                          CEP/COS

                                                                                          Close CEP/COS

                                                                                          Japanese DMF

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                                                                                          Written Confirmation

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                                                                                          Application Number
                                                                                          37015
                                                                                          Status
                                                                                          Active
                                                                                          Fees Unpaid
                                                                                          N/A
                                                                                           
                                                                                          Filing Details
                                                                                          OZANIMOD HYDROCHLORIDE
                                                                                          Issue/Submission Date
                                                                                          2022-03-31
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                                                                                            Ozenoxacin

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                                                                                            USDMF

                                                                                            Found USDMF

                                                                                            34898
                                                                                            Active
                                                                                            OZENOXACIN
                                                                                            2020-06-01
                                                                                            CEP/COS

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                                                                                            Japanese DMF

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                                                                                            Written Confirmation

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                                                                                            Application Number
                                                                                            34898
                                                                                            Status
                                                                                            Active
                                                                                            Fees Unpaid
                                                                                            N/A
                                                                                             
                                                                                            Filing Details
                                                                                            OZENOXACIN
                                                                                            Issue/Submission Date
                                                                                            2020-06-01
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                                                                                              USDMF

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                                                                                              35243
                                                                                              Active
                                                                                              PENCICLOVIR
                                                                                              2020-09-26
                                                                                              CEP/COS

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                                                                                              Japanese DMF

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                                                                                              Written Confirmation

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                                                                                              Application Number
                                                                                              35243
                                                                                              Status
                                                                                              Active
                                                                                              Fees Unpaid
                                                                                              Reviewed
                                                                                               
                                                                                              Filing Details
                                                                                              PENCICLOVIR
                                                                                              Issue/Submission Date
                                                                                              2020-09-26
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                                                                                                Raltegravir Potassium

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                                                                                                36083
                                                                                                Active
                                                                                                RALTEGRAVIR POTASSIUM USP
                                                                                                2021-06-30
                                                                                                CEP/COS

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                                                                                                Japanese DMF

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                                                                                                Application Number
                                                                                                36083
                                                                                                Status
                                                                                                Active
                                                                                                Fees Unpaid
                                                                                                N/A
                                                                                                 
                                                                                                Filing Details
                                                                                                RALTEGRAVIR POTASSIUM USP
                                                                                                Issue/Submission Date
                                                                                                2021-06-30
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                                                                                                  USDMF

                                                                                                  Found USDMF

                                                                                                  36797
                                                                                                  Active
                                                                                                  ROXADUSTAT
                                                                                                  2022-02-16
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                                                                                                  Japanese DMF

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                                                                                                  Application Number
                                                                                                  36797
                                                                                                  Status
                                                                                                  Active
                                                                                                  Fees Unpaid
                                                                                                  N/A
                                                                                                   
                                                                                                  Filing Details
                                                                                                  ROXADUSTAT
                                                                                                  Issue/Submission Date
                                                                                                  2022-02-16
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                                                                                                    Selexipag

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                                                                                                    USDMF

                                                                                                    Found USDMF

                                                                                                    33561
                                                                                                    Active
                                                                                                    SELEXIPAG (FORM-I)
                                                                                                    2019-03-07
                                                                                                    CEP/COS

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                                                                                                    Japanese DMF

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                                                                                                    Application Number
                                                                                                    33561
                                                                                                    Status
                                                                                                    Active
                                                                                                    Fees Unpaid
                                                                                                    N/A
                                                                                                     
                                                                                                    Filing Details
                                                                                                    SELEXIPAG (FORM-I)
                                                                                                    Issue/Submission Date
                                                                                                    2019-03-07
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                                                                                                      USDMF

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                                                                                                      36155
                                                                                                      Active
                                                                                                      SELEXIPAG (FORM-III)
                                                                                                      2021-07-31
                                                                                                      CEP/COS

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                                                                                                      Japanese DMF

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                                                                                                      Application Number
                                                                                                      36155
                                                                                                      Status
                                                                                                      Active
                                                                                                      Fees Unpaid
                                                                                                      N/A
                                                                                                       
                                                                                                      Filing Details
                                                                                                      SELEXIPAG (FORM-III)
                                                                                                      Issue/Submission Date
                                                                                                      2021-07-31
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                                                                                                        Siponimod fumarate

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                                                                                                        USDMF

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                                                                                                        36596
                                                                                                        Active
                                                                                                        SIPONIMOD FUMARIC ACID
                                                                                                        2021-12-09
                                                                                                        CEP/COS

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                                                                                                        Application Number
                                                                                                        36596
                                                                                                        Status
                                                                                                        Active
                                                                                                        Fees Unpaid
                                                                                                        Reviewed
                                                                                                         
                                                                                                        Filing Details
                                                                                                        SIPONIMOD FUMARIC ACID
                                                                                                        Issue/Submission Date
                                                                                                        2021-12-09
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