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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Chromo Laboratories

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    India
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    Medak District, Andhra Pradesh - 502307
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      Atazanavir Sulfate

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      USDMF

      Found USDMF

      33585
      Active
      ATAZANAVIR SULFATE USP
      2021-11-27
      CEP/COS

      Found CEP/COS

      R0-CEP 2019-177 - Rev 00
      Valid
      Atazanavir sulfate
      2022-09-21
      Japanese DMF

      Close JDMF

      Written Confirmation

      Found WC

      Indian CDSCO WC-0317
      Valid
      Atazanavir Sulfate EP
      2022-02-02
      Application Number
      33585
      R0-CEP 2019-177 - Rev 00
      Indian CDSCO WC-0317
      Status
      Active
      Fees Paid
      N/A
      Valid
       
      Valid
      2024-06-07
      Filing Details
      ATAZANAVIR SULFATE USP
      Atazanavir sulfate
      Atazanavir Sulfate EP
      Issue/Submission Date
      2021-11-27
      2022-09-21
      2022-02-02
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        Atorvastatin

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        USDMF

        Found USDMF

        33584
        Active
        ATORVASTATIN CALCIUM TRIHYDRATE USP
        2019-03-05
        CEP/COS

        Found CEP/COS

        R1-CEP 2015-288 - Rev 00
        Valid
        Atorvastatin calcium
        2023-06-05
        Japanese DMF

        Close JDMF

        Written Confirmation

        Found WC

        Indian CDSCO WC-0317
        Valid
        Atorvastatin Calcium (USP/IP) Atorv...
        2022-02-02
        Application Number
        33584
        R1-CEP 2015-288 - Rev 00
        Indian CDSCO WC-0317
        Status
        Active
        Fees Paid
        Reviewed
        Valid
         
        Valid
        2024-06-07
        Filing Details
        ATORVASTATIN CALCIUM TRIHYDRATE USP
        Atorvastatin calcium
        Atorvastatin Calcium (USP/IP) Atorv...
        Issue/Submission Date
        2019-03-05
        2023-06-05
        2022-02-02
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          Candesartan Cilexetil

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          USDMF

          Found USDMF

          25797
          Active
          CANDESARTAN CILEXETIL USP
          2012-02-17
          CEP/COS

          Found CEP/COS

          R1-CEP 2011-367 - Rev 03
          Valid
          Candesartan cilexetil
          2023-06-22
          Japanese DMF

          Close JDMF

          Written Confirmation

          Found WC

          Indian CDSCO WC-0317
          Valid
          Candesartan Cilexetil (USP/BP/EP)
          2022-02-02
          Application Number
          25797
          R1-CEP 2011-367 - Rev 03
          Indian CDSCO WC-0317
          Status
          Active
          Fees Paid
          N/A
          Valid
           
          Valid
          2024-06-07
          Filing Details
          CANDESARTAN CILEXETIL USP
          Candesartan cilexetil
          Candesartan Cilexetil (USP/BP/EP)
          Issue/Submission Date
          2012-02-17
          2023-06-22
          2022-02-02
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            Chlorthalidone

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            USDMF

            Found USDMF

            33071
            Active
            CHLORTHALIDONE USP
            2018-08-30
            CEP/COS

            Found CEP/COS

            R0-CEP 2018-175 - Rev 02
            Valid
            Chlortalidone
            2023-05-24
            Japanese DMF

            Close JDMF

            Written Confirmation

            Found WC

            Indian CDSCO WC-0317
            Valid
            Chlorthalidone USP/EP
            2022-02-02
            Application Number
            33071
            R0-CEP 2018-175 - Rev 02
            Indian CDSCO WC-0317
            Status
            Active
            Fees Paid
            N/A
            Valid
             
            Valid
            2024-06-07
            Filing Details
            CHLORTHALIDONE USP
            Chlortalidone
            Chlorthalidone USP/EP
            Issue/Submission Date
            2018-08-30
            2023-05-24
            2022-02-02
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              Modafinil

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              USDMF

              Found USDMF

              36975
              Active
              MODAFINIL USP
              2022-04-23
              CEP/COS

              Found CEP/COS

              CEP 2022-186 - Rev 00
              Valid
              Modafinil
              2023-12-06
              Japanese DMF

              Close JDMF

              Written Confirmation

              Found WC

              Indian CDSCO WC-0317
              Valid
              Modafinil USP/EP
              2022-02-02
              Application Number
              36975
              CEP 2022-186 - Rev 00
              Indian CDSCO WC-0317
              Status
              Active
              Fees Paid
              N/A
              Valid
               
              Valid
              2024-06-07
              Filing Details
              MODAFINIL USP
              Modafinil
              Modafinil USP/EP
              Issue/Submission Date
              2022-04-23
              2023-12-06
              2022-02-02
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                Olanzapine

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                USDMF

                Found USDMF

                33221
                Active
                OLANZAPINE USP
                2022-07-15
                CEP/COS

                Found CEP/COS

                R0-CEP 2019-304 - Rev 00
                Valid
                Olanzapine
                2023-01-17
                Japanese DMF

                Close JDMF

                Written Confirmation

                Found WC

                Indian CDSCO WC-0317
                Valid
                Olanzapine USP
                2022-02-02
                Application Number
                33221
                R0-CEP 2019-304 - Rev 00
                Indian CDSCO WC-0317
                Status
                Active
                Fees Paid
                N/A
                Valid
                 
                Valid
                2024-06-07
                Filing Details
                OLANZAPINE USP
                Olanzapine
                Olanzapine USP
                Issue/Submission Date
                2022-07-15
                2023-01-17
                2022-02-02
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                  Olmesartan Medoxomil

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                  USDMF

                  Found USDMF

                  33587
                  Active
                  OLMESARTAN MEDOXOMIL USP
                  2019-04-13
                  CEP/COS

                  Found CEP/COS

                  R0-CEP 2018-083 - Rev 03
                  Valid
                  Olmesartan medoxomil
                  2023-08-03
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Found WC

                  Indian CDSCO WC-0317
                  Valid
                  Olmesartan medoximil USP/EP
                  2022-02-02
                  Application Number
                  33587
                  R0-CEP 2018-083 - Rev 03
                  Indian CDSCO WC-0317
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Valid
                  2024-06-07
                  Filing Details
                  OLMESARTAN MEDOXOMIL USP
                  Olmesartan medoxomil
                  Olmesartan medoximil USP/EP
                  Issue/Submission Date
                  2019-04-13
                  2023-08-03
                  2022-02-02
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                    Repaglinide

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                    USDMF

                    Found USDMF

                    26396
                    Active
                    REPAGLINIDE USP
                    2012-09-10
                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2012-087 - Rev 00
                    Valid
                    Repaglinide
                    2018-09-27
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Found WC

                    Indian CDSCO WC-0317
                    Valid
                    Repaglinide (USP/EP/BP)
                    2022-02-02
                    Application Number
                    26396
                    R1-CEP 2012-087 - Rev 00
                    Indian CDSCO WC-0317
                    Status
                    Active
                    Fees Paid
                    N/A
                    Valid
                     
                    Valid
                    2024-06-07
                    Filing Details
                    REPAGLINIDE USP
                    Repaglinide
                    Repaglinide (USP/EP/BP)
                    Issue/Submission Date
                    2012-09-10
                    2018-09-27
                    2022-02-02
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                      Telmisartan

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                      USDMF

                      Found USDMF

                      33989
                      Active
                      TELMISARTAN USP
                      2019-07-13
                      CEP/COS

                      Found CEP/COS

                      R0-CEP 2018-104 - Rev 01
                      Valid
                      Telmisartan
                      2021-11-29
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Found WC

                      Indian CDSCO WC-0317
                      Valid
                      Telmisartan USP/EP
                      2022-02-02
                      Application Number
                      33989
                      R0-CEP 2018-104 - Rev 01
                      Indian CDSCO WC-0317
                      Status
                      Active
                      Fees Paid
                      N/A
                      Valid
                       
                      Valid
                      2024-06-07
                      Filing Details
                      TELMISARTAN USP
                      Telmisartan
                      Telmisartan USP/EP
                      Issue/Submission Date
                      2019-07-13
                      2021-11-29
                      2022-02-02
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                        Terbinafine Hydrochloride

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                        USDMF

                        Found USDMF

                        31719
                        Active
                        TERBINAFINE HYDROCHLORIDE USP
                        2017-07-12
                        CEP/COS

                        Found CEP/COS

                        CEP 2017-102 - Rev 02
                        Valid
                        Terbinafine hydrochloride
                        2024-04-10
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Found WC

                        Indian CDSCO WC-0317
                        Valid
                        Terbinafine Hydrochloride (EP/BP/US...
                        2022-02-02
                        Application Number
                        31719
                        CEP 2017-102 - Rev 02
                        Indian CDSCO WC-0317
                        Status
                        Active
                        Fees Paid
                        Reviewed
                        Valid
                         
                        Valid
                        2024-06-07
                        Filing Details
                        TERBINAFINE HYDROCHLORIDE USP
                        Terbinafine hydrochloride
                        Terbinafine Hydrochloride (EP/BP/US...
                        Issue/Submission Date
                        2017-07-12
                        2024-04-10
                        2022-02-02
                        ASK
                        US
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                          Voriconazole

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                          USDMF

                          Found USDMF

                          31709
                          Active
                          VORICONAZOLE USP
                          2017-06-22
                          CEP/COS

                          Found CEP/COS

                          R1-CEP 2013-171 - Rev 01
                          Valid
                          Voriconazole
                          2022-11-10
                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Found WC

                          Indian CDSCO WC-0317
                          Valid
                          Voriconazole (BP/USP/EP/IH)
                          2022-02-02
                          Application Number
                          31709
                          R1-CEP 2013-171 - Rev 01
                          Indian CDSCO WC-0317
                          Status
                          Active
                          Fees Paid
                          N/A
                          Valid
                           
                          Valid
                          2024-06-07
                          Filing Details
                          VORICONAZOLE USP
                          Voriconazole
                          Voriconazole (BP/USP/EP/IH)
                          Issue/Submission Date
                          2017-06-22
                          2022-11-10
                          2022-02-02
                          ASK
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                            Valsartan

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                            USDMF

                            Caution USDMF

                            33586
                            Inactive
                            VALSARTAN USP
                            2019-03-28
                            CEP/COS

                            Found CEP/COS

                            R0-CEP 2018-116 - Rev 01
                            Valid
                            Valsartan
                            2022-09-12
                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Found WC

                            Indian CDSCO WC-0317
                            Valid
                            Valsartan (BP/EP/USP/IP)
                            2022-02-02
                            Application Number
                            33586
                            R0-CEP 2018-116 - Rev 01
                            Indian CDSCO WC-0317
                            Status
                            Inactive
                            Fees Paid
                            N/A
                            Valid
                             
                            Valid
                            2024-06-07
                            Filing Details
                            VALSARTAN USP
                            Valsartan
                            Valsartan (BP/EP/USP/IP)
                            Issue/Submission Date
                            2019-03-28
                            2022-09-12
                            2022-02-02
                            ASK
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                              Ziprasidone Hydrochloride

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                              USDMF

                              Found USDMF

                              33991
                              Active
                              ZIPRASIDONE HYDROCHLORIDE USP
                              2019-07-20
                              CEP/COS

                              Found CEP/COS

                              R0-CEP 2018-110 - Rev 01
                              Valid
                              Ziprasidone hydrochloride monohydra...
                              2021-10-07
                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Caution WC

                              Indian CDSCO WC-0317A2
                              Expired
                              Ziprasidone HCl USP/EP
                              2020-11-27
                              Application Number
                              33991
                              R0-CEP 2018-110 - Rev 01
                              Indian CDSCO WC-0317A2
                              Status
                              Active
                              Fees Paid
                              N/A
                              Valid
                               
                              Expired
                              2021-06-07
                              Filing Details
                              ZIPRASIDONE HYDROCHLORIDE USP
                              Ziprasidone hydrochloride monohydra...
                              Ziprasidone HCl USP/EP
                              Issue/Submission Date
                              2019-07-20
                              2021-10-07
                              2020-11-27
                              ASK
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                                Dolutegravir Sodium

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                                USDMF

                                Found USDMF

                                33992
                                Active
                                DOLUTEGRAVIR SODIUM
                                2021-03-24
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Found WC

                                Indian CDSCO WC-0317
                                Valid
                                Dolutegravir Sodium IH
                                2022-02-02
                                Application Number
                                33992
                                Indian CDSCO WC-0317
                                Status
                                Active
                                Fees Paid
                                N/A
                                 
                                Valid
                                2024-06-07
                                Filing Details
                                DOLUTEGRAVIR SODIUM
                                Dolutegravir Sodium IH
                                Issue/Submission Date
                                2021-03-24
                                2022-02-02
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                                  Esomeprazole Magnesium

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                                  USDMF

                                  Found USDMF

                                  36952
                                  Active
                                  ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
                                  2022-07-14
                                  CEP/COS

                                  Found CEP/COS

                                  R0-CEP 2021-010 - Rev 00
                                  Valid
                                  Esomeprazole magnesium trihydrate
                                  2022-11-29
                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  36952
                                  R0-CEP 2021-010 - Rev 00
                                  Status
                                  Active
                                  Fees Paid
                                  N/A
                                  Valid
                                   
                                  Filing Details
                                  ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
                                  Esomeprazole magnesium trihydrate
                                  Issue/Submission Date
                                  2022-07-14
                                  2022-11-29
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                                    Lansoprazole

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                                    USDMF

                                    Found USDMF

                                    35305
                                    Active
                                    LANSOPRAZOLE USP
                                    2021-03-16
                                    CEP/COS

                                    Found CEP/COS

                                    R0-CEP 2020-424 - Rev 01
                                    Valid
                                    Lansoprazole
                                    2023-01-13
                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    35305
                                    R0-CEP 2020-424 - Rev 01
                                    Status
                                    Active
                                    Fees Paid
                                    N/A
                                    Valid
                                     
                                    Filing Details
                                    LANSOPRAZOLE USP
                                    Lansoprazole
                                    Issue/Submission Date
                                    2021-03-16
                                    2023-01-13
                                    ASK
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                                      Levocetirizine Dihydrochloride

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                                      USDMF

                                      Found USDMF

                                      33219
                                      Active
                                      LEVOCETIRIZINE DIHYDROCHLORIDE USP
                                      2019-03-16
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Found WC

                                      Indian CDSCO WC-0317
                                      Valid
                                      Levocetrizine Dihcl USP
                                      2022-02-02
                                      Application Number
                                      33219
                                      Indian CDSCO WC-0317
                                      Status
                                      Active
                                      Fees Paid
                                      Reviewed
                                       
                                      Valid
                                      2024-06-07
                                      Filing Details
                                      LEVOCETIRIZINE DIHYDROCHLORIDE USP
                                      Levocetrizine Dihcl USP
                                      Issue/Submission Date
                                      2019-03-16
                                      2022-02-02
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                                        Linezolid

                                        PDF Supplier PDF
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                                        USDMF

                                        Found USDMF

                                        35304
                                        Active
                                        LINEZOLID USP
                                        2020-11-26
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Found WC

                                        Indian CDSCO WC-0317
                                        Valid
                                        Linezolid USP
                                        2022-02-02
                                        Application Number
                                        35304
                                        Indian CDSCO WC-0317
                                        Status
                                        Active
                                        Fees Paid
                                        Reviewed
                                         
                                        Valid
                                        2024-06-07
                                        Filing Details
                                        LINEZOLID USP
                                        Linezolid USP
                                        Issue/Submission Date
                                        2020-11-26
                                        2022-02-02
                                        ASK
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                                          Moxifloxacin Hydrochloride

                                          PDF Supplier PDF
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                                          USDMF

                                          Found USDMF

                                          31720
                                          Active
                                          MOXIFLOXACIN HYDROCHLORIDE USP
                                          2019-05-09
                                          CEP/COS

                                          Found CEP/COS

                                          CEP 2016-327 - Rev 04
                                          Valid
                                          Moxifloxacin hydrochloride
                                          2023-10-31
                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          31720
                                          CEP 2016-327 - Rev 04
                                          Status
                                          Active
                                          Fees Paid
                                          N/A
                                          Valid
                                           
                                          Filing Details
                                          MOXIFLOXACIN HYDROCHLORIDE USP
                                          Moxifloxacin hydrochloride
                                          Issue/Submission Date
                                          2019-05-09
                                          2023-10-31
                                          ASK
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                                            Oseltamivir Phosphate

                                            PDF Supplier PDF
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                                            USDMF

                                            Found USDMF

                                            36971
                                            Active
                                            OSELTAMIVIR PHOSPHATE USP
                                            2022-07-05
                                            CEP/COS

                                            Found CEP/COS

                                            CEP 2022-289 - Rev 00
                                            Valid
                                            Oseltamivir phosphate
                                            2024-04-09
                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            36971
                                            CEP 2022-289 - Rev 00
                                            Status
                                            Active
                                            Fees Paid
                                            N/A
                                            Valid
                                             
                                            Filing Details
                                            OSELTAMIVIR PHOSPHATE USP
                                            Oseltamivir phosphate
                                            Issue/Submission Date
                                            2022-07-05
                                            2024-04-09
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                                              Praziquantel

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                                              USDMF

                                              Found USDMF

                                              35306
                                              Active
                                              PRAZIQUANTEL USP
                                              2021-06-02
                                              CEP/COS

                                              Found CEP/COS

                                              R0-CEP 2021-096 - Rev 00
                                              Valid
                                              Praziquantel
                                              2023-06-19
                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              35306
                                              R0-CEP 2021-096 - Rev 00
                                              Status
                                              Active
                                              Fees Paid
                                              N/A
                                              Valid
                                               
                                              Filing Details
                                              PRAZIQUANTEL USP
                                              Praziquantel
                                              Issue/Submission Date
                                              2021-06-02
                                              2023-06-19
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                                                Ritonavir

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                                                USDMF

                                                Found USDMF

                                                35303
                                                Active
                                                RITONAVIR USP
                                                2020-11-21
                                                CEP/COS

                                                Found CEP/COS

                                                R0-CEP 2020-345 - Rev 00
                                                Valid
                                                Ritonavir
                                                2023-03-31
                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                35303
                                                R0-CEP 2020-345 - Rev 00
                                                Status
                                                Active
                                                Fees Paid
                                                N/A
                                                Valid
                                                 
                                                Filing Details
                                                RITONAVIR USP
                                                Ritonavir
                                                Issue/Submission Date
                                                2020-11-21
                                                2023-03-31
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                                                  Rosuvastatin Calcium

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                                                  USDMF

                                                  Found USDMF

                                                  36208
                                                  Active
                                                  ROSUVASTATIN CALCIUM USP
                                                  2022-05-05
                                                  CEP/COS

                                                  Found CEP/COS

                                                  R0-CEP 2022-009 - Rev 00
                                                  Valid
                                                  Rosuvastatin calcium
                                                  2023-06-01
                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  36208
                                                  R0-CEP 2022-009 - Rev 00
                                                  Status
                                                  Active
                                                  Fees Paid
                                                  N/A
                                                  Valid
                                                   
                                                  Filing Details
                                                  ROSUVASTATIN CALCIUM USP
                                                  Rosuvastatin calcium
                                                  Issue/Submission Date
                                                  2022-05-05
                                                  2023-06-01
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                                                    Sumatriptan

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                                                    USDMF

                                                    Found USDMF

                                                    36972
                                                    Active
                                                    SUMATRIPTAN SUCCINATE USP
                                                    2022-07-05
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Found WC

                                                    Indian CDSCO WC-0317
                                                    Valid
                                                    Sumatriptan Succinate USP/EP
                                                    2022-02-02
                                                    Application Number
                                                    36972
                                                    Indian CDSCO WC-0317
                                                    Status
                                                    Active
                                                    Fees Paid
                                                    N/A
                                                     
                                                    Valid
                                                    2024-06-07
                                                    Filing Details
                                                    SUMATRIPTAN SUCCINATE USP
                                                    Sumatriptan Succinate USP/EP
                                                    Issue/Submission Date
                                                    2022-07-05
                                                    2022-02-02
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                                                      Vardenafil Hydrochloride

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                                                      USDMF

                                                      Found USDMF

                                                      33220
                                                      Active
                                                      VARDENAFIL HYDROCHLORIDE TRIHYDRATE...
                                                      2019-03-07
                                                      CEP/COS

                                                      Close CEP/COS

                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Found WC

                                                      Indian CDSCO WC-0317
                                                      Valid
                                                      Vardenafil HCl USP/ Vardenafil HCl ...
                                                      2022-02-02
                                                      Application Number
                                                      33220
                                                      Indian CDSCO WC-0317
                                                      Status
                                                      Active
                                                      Fees Paid
                                                      N/A
                                                       
                                                      Valid
                                                      2024-06-07
                                                      Filing Details
                                                      VARDENAFIL HYDROCHLORIDE TRIHYDRATE...
                                                      Vardenafil HCl USP/ Vardenafil HCl ...
                                                      Issue/Submission Date
                                                      2019-03-07
                                                      2022-02-02
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                                                        Zafirlukast

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                                                        USDMF

                                                        Found USDMF

                                                        26359
                                                        Active
                                                        ZAFIRLUKAST PREMIX-50% W/W
                                                        2012-09-28
                                                        CEP/COS

                                                        Close CEP/COS

                                                        Japanese DMF

                                                        Close JDMF

                                                        Written Confirmation

                                                        Found WC

                                                        Indian CDSCO WC-0317
                                                        Valid
                                                        Zafirlukast (IH)
                                                        2022-02-02
                                                        Application Number
                                                        26359
                                                        Indian CDSCO WC-0317
                                                        Status
                                                        Active
                                                        Fees Paid
                                                        Reviewed
                                                         
                                                        Valid
                                                        2024-06-07
                                                        Filing Details
                                                        ZAFIRLUKAST PREMIX-50% W/W
                                                        Zafirlukast (IH)
                                                        Issue/Submission Date
                                                        2012-09-28
                                                        2022-02-02
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                                                          Aminocaproic Acid

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                                                          USDMF

                                                          Close USDMF

                                                          CEP/COS

                                                          Close CEP/COS

                                                          Japanese DMF

                                                          Close JDMF

                                                          Written Confirmation

                                                          Found WC

                                                          Indian CDSCO WC-0317
                                                          Valid
                                                          Aminocaproic Acid USP
                                                          2022-02-02
                                                          Application Number
                                                          Indian CDSCO WC-0317
                                                          Status
                                                           
                                                          Valid
                                                          2024-06-07
                                                          Filing Details
                                                          Aminocaproic Acid USP
                                                          Issue/Submission Date
                                                          2022-02-02
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                                                            CHEBI:53757

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                                                            USDMF

                                                            Found USDMF

                                                            36970
                                                            Active
                                                            ZIPRASIDONE MESILATE TRIHYDRATE
                                                            2023-05-15
                                                            CEP/COS

                                                            Close CEP/COS

                                                            Japanese DMF

                                                            Close JDMF

                                                            Written Confirmation

                                                            Close WC

                                                            Application Number
                                                            36970
                                                            Status
                                                            Active
                                                            Fees Paid
                                                            N/A
                                                             
                                                            Filing Details
                                                            ZIPRASIDONE MESILATE TRIHYDRATE
                                                            Issue/Submission Date
                                                            2023-05-15
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                                                              Chlorpromazine Hydrochloride

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                                                              USDMF

                                                              Close USDMF

                                                              CEP/COS

                                                              Close CEP/COS

                                                              Japanese DMF

                                                              Close JDMF

                                                              Written Confirmation

                                                              Found WC

                                                              Indian CDSCO WC-0317
                                                              Valid
                                                              Chlorpromazine HCl USP/EP
                                                              2022-02-02
                                                              Application Number
                                                              Indian CDSCO WC-0317
                                                              Status
                                                               
                                                              Valid
                                                              2024-06-07
                                                              Filing Details
                                                              Chlorpromazine HCl USP/EP
                                                              Issue/Submission Date
                                                              2022-02-02
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                                                                Dexlansoprazole

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                                                                USDMF

                                                                Found USDMF

                                                                37442
                                                                Active
                                                                DEXLANSOPRAZOLE SESQUIHYDRATE
                                                                2022-08-23
                                                                CEP/COS

                                                                Close CEP/COS

                                                                Japanese DMF

                                                                Close JDMF

                                                                Written Confirmation

                                                                Close WC

                                                                Application Number
                                                                37442
                                                                Status
                                                                Active
                                                                Fees Paid
                                                                N/A
                                                                 
                                                                Filing Details
                                                                DEXLANSOPRAZOLE SESQUIHYDRATE
                                                                Issue/Submission Date
                                                                2022-08-23
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                                                                  Eszopiclone

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                                                                  USDMF

                                                                  Close USDMF

                                                                  CEP/COS

                                                                  Close CEP/COS

                                                                  Japanese DMF

                                                                  Close JDMF

                                                                  Written Confirmation

                                                                  Found WC

                                                                  Indian CDSCO WC-0317
                                                                  Valid
                                                                  Eszopiclone USP
                                                                  2022-02-02
                                                                  Application Number
                                                                  Indian CDSCO WC-0317
                                                                  Status
                                                                   
                                                                  Valid
                                                                  2024-06-07
                                                                  Filing Details
                                                                  Eszopiclone USP
                                                                  Issue/Submission Date
                                                                  2022-02-02
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                                                                    Granisetron Hydrochloride

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                                                                    USDMF

                                                                    Close USDMF

                                                                    CEP/COS

                                                                    Close CEP/COS

                                                                    Japanese DMF

                                                                    Close JDMF

                                                                    Written Confirmation

                                                                    Found WC

                                                                    Indian CDSCO WC-0317
                                                                    Valid
                                                                    Granisetron HCl USP/EP
                                                                    2022-02-02
                                                                    Application Number
                                                                    Indian CDSCO WC-0317
                                                                    Status
                                                                     
                                                                    Valid
                                                                    2024-06-07
                                                                    Filing Details
                                                                    Granisetron HCl USP/EP
                                                                    Issue/Submission Date
                                                                    2022-02-02
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                                                                      Ibandronate Sodium

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                                                                      USDMF

                                                                      Close USDMF

                                                                      CEP/COS

                                                                      Close CEP/COS

                                                                      Japanese DMF

                                                                      Close JDMF

                                                                      Written Confirmation

                                                                      Found WC

                                                                      Indian CDSCO WC-0317
                                                                      Valid
                                                                      Ibandronate Sodium IH
                                                                      2022-02-02
                                                                      Application Number
                                                                      Indian CDSCO WC-0317
                                                                      Status
                                                                       
                                                                      Valid
                                                                      2024-06-07
                                                                      Filing Details
                                                                      Ibandronate Sodium IH
                                                                      Issue/Submission Date
                                                                      2022-02-02
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                                                                        Levofloxacin Hemihydrate

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                                                                        USDMF

                                                                        Close USDMF

                                                                        CEP/COS

                                                                        Close CEP/COS

                                                                        Japanese DMF

                                                                        Close JDMF

                                                                        Written Confirmation

                                                                        Found WC

                                                                        Indian CDSCO WC-0317
                                                                        Valid
                                                                        Levofloxacin Hemihydrate USP/EP
                                                                        2022-02-02
                                                                        Application Number
                                                                        Indian CDSCO WC-0317
                                                                        Status
                                                                         
                                                                        Valid
                                                                        2024-06-07
                                                                        Filing Details
                                                                        Levofloxacin Hemihydrate USP/EP
                                                                        Issue/Submission Date
                                                                        2022-02-02
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                                                                          Naratriptan Hydrochloride

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                                                                          USDMF

                                                                          Close USDMF

                                                                          CEP/COS

                                                                          Close CEP/COS

                                                                          Japanese DMF

                                                                          Close JDMF

                                                                          Written Confirmation

                                                                          Found WC

                                                                          Indian CDSCO WC-0317
                                                                          Valid
                                                                          Naratriptan HCl USP
                                                                          2022-02-02
                                                                          Application Number
                                                                          Indian CDSCO WC-0317
                                                                          Status
                                                                           
                                                                          Valid
                                                                          2024-06-07
                                                                          Filing Details
                                                                          Naratriptan HCl USP
                                                                          Issue/Submission Date
                                                                          2022-02-02
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                                                                            Rosuvastatin Calcium

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                                                                            USDMF

                                                                            Found USDMF

                                                                            37220
                                                                            Active
                                                                            ROSUVASTATIN CALCIUM USP
                                                                            2023-04-26
                                                                            CEP/COS

                                                                            Close CEP/COS

                                                                            Japanese DMF

                                                                            Close JDMF

                                                                            Written Confirmation

                                                                            Close WC

                                                                            Application Number
                                                                            37220
                                                                            Status
                                                                            Active
                                                                            Fees Paid
                                                                            N/A
                                                                             
                                                                            Filing Details
                                                                            ROSUVASTATIN CALCIUM USP
                                                                            Issue/Submission Date
                                                                            2023-04-26
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                                                                              Tenofovir Disoproxil Fumarate

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                                                                              USDMF

                                                                              Found USDMF

                                                                              35308
                                                                              Active
                                                                              TENOFOVIR DISOPROXIL FUMARATE
                                                                              2021-11-11
                                                                              CEP/COS

                                                                              Close CEP/COS

                                                                              Japanese DMF

                                                                              Close JDMF

                                                                              Written Confirmation

                                                                              Close WC

                                                                              Application Number
                                                                              35308
                                                                              Status
                                                                              Active
                                                                              Fees Paid
                                                                              N/A
                                                                               
                                                                              Filing Details
                                                                              TENOFOVIR DISOPROXIL FUMARATE
                                                                              Issue/Submission Date
                                                                              2021-11-11
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                                                                                Zafirlukast

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                                                                                USDMF

                                                                                Found USDMF

                                                                                31869
                                                                                Active
                                                                                ZAFIRLUKAST
                                                                                2017-08-18
                                                                                CEP/COS

                                                                                Close CEP/COS

                                                                                Japanese DMF

                                                                                Close JDMF

                                                                                Written Confirmation

                                                                                Close WC

                                                                                Application Number
                                                                                31869
                                                                                Status
                                                                                Active
                                                                                Fees Paid
                                                                                N/A
                                                                                 
                                                                                Filing Details
                                                                                ZAFIRLUKAST
                                                                                Issue/Submission Date
                                                                                2017-08-18
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                                                                                  Zaleplon

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                                                                                  USDMF

                                                                                  Close USDMF

                                                                                  CEP/COS

                                                                                  Close CEP/COS

                                                                                  Japanese DMF

                                                                                  Close JDMF

                                                                                  Written Confirmation

                                                                                  Found WC

                                                                                  Indian CDSCO WC-0317
                                                                                  Valid
                                                                                  Zaleplon USP
                                                                                  2022-02-02
                                                                                  Application Number
                                                                                  Indian CDSCO WC-0317
                                                                                  Status
                                                                                   
                                                                                  Valid
                                                                                  2024-06-07
                                                                                  Filing Details
                                                                                  Zaleplon USP
                                                                                  Issue/Submission Date
                                                                                  2022-02-02
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                                                                                    PREGABALIN USP

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                                                                                    USDMF

                                                                                    Found USDMF

                                                                                    36966
                                                                                    Active
                                                                                    PREGABALIN USP
                                                                                    2023-08-23
                                                                                    CEP/COS

                                                                                    Close CEP/COS

                                                                                    Japanese DMF

                                                                                    Close JDMF

                                                                                    Written Confirmation

                                                                                    Close WC

                                                                                    Application Number
                                                                                    36966
                                                                                    Status
                                                                                    Active
                                                                                    Fees Paid
                                                                                    N/A
                                                                                     
                                                                                    Filing Details
                                                                                    PREGABALIN USP
                                                                                    Issue/Submission Date
                                                                                    2023-08-23
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                                                                                      Aminocaproic Acid

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                                                                                      USDMF

                                                                                      Close USDMF

                                                                                      CEP/COS

                                                                                      Close CEP/COS

                                                                                      Japanese DMF

                                                                                      Close JDMF

                                                                                      Written Confirmation

                                                                                      Caution WC

                                                                                      Indian CDSCO WC-0317A2
                                                                                      Expired
                                                                                      Aminocaproic Acid USP
                                                                                      2020-11-27
                                                                                      Application Number
                                                                                      Indian CDSCO WC-0317A2
                                                                                      Status
                                                                                       
                                                                                      Expired
                                                                                      2021-06-07
                                                                                      Filing Details
                                                                                      Aminocaproic Acid USP
                                                                                      Issue/Submission Date
                                                                                      2020-11-27
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                                                                                        Atazanavir Sulfate

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                                                                                        USDMF

                                                                                        Close USDMF

                                                                                        CEP/COS

                                                                                        Close CEP/COS

                                                                                        Japanese DMF

                                                                                        Close JDMF

                                                                                        Written Confirmation

                                                                                        Caution WC

                                                                                        Indian CDSCO WC-0317A2
                                                                                        Expired
                                                                                        Atazanavir Sulfate EP
                                                                                        2020-11-27
                                                                                        Application Number
                                                                                        Indian CDSCO WC-0317A2
                                                                                        Status
                                                                                         
                                                                                        Expired
                                                                                        2021-06-07
                                                                                        Filing Details
                                                                                        Atazanavir Sulfate EP
                                                                                        Issue/Submission Date
                                                                                        2020-11-27
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                                                                                          Chlorpromazine Hydrochloride

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                                                                                          USDMF

                                                                                          Close USDMF

                                                                                          CEP/COS

                                                                                          Close CEP/COS

                                                                                          Japanese DMF

                                                                                          Close JDMF

                                                                                          Written Confirmation

                                                                                          Caution WC

                                                                                          Indian CDSCO WC-0317A2
                                                                                          Expired
                                                                                          Chlorpromazine HCL/EP
                                                                                          2020-11-27
                                                                                          Application Number
                                                                                          Indian CDSCO WC-0317A2
                                                                                          Status
                                                                                           
                                                                                          Expired
                                                                                          2021-06-07
                                                                                          Filing Details
                                                                                          Chlorpromazine HCL/EP
                                                                                          Issue/Submission Date
                                                                                          2020-11-27
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                                                                                            Chlorthalidone

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                                                                                            Indian CDSCO WC-0317A2
                                                                                            Expired
                                                                                            Chlorthalidone USP/EP
                                                                                            2020-11-27
                                                                                            Application Number
                                                                                            Indian CDSCO WC-0317A2
                                                                                            Status
                                                                                             
                                                                                            Expired
                                                                                            2021-06-07
                                                                                            Filing Details
                                                                                            Chlorthalidone USP/EP
                                                                                            Issue/Submission Date
                                                                                            2020-11-27
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                                                                                              Dolutegravir Sodium

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                                                                                              Indian CDSCO WC-0317A2
                                                                                              Expired
                                                                                              Dolutegravir Sodium IH
                                                                                              2020-11-27
                                                                                              Application Number
                                                                                              Indian CDSCO WC-0317A2
                                                                                              Status
                                                                                               
                                                                                              Expired
                                                                                              2021-06-07
                                                                                              Filing Details
                                                                                              Dolutegravir Sodium IH
                                                                                              Issue/Submission Date
                                                                                              2020-11-27
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                                                                                                Eszopiclone

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                                                                                                Indian CDSCO WC-0317A2
                                                                                                Expired
                                                                                                Eszopiclone USP
                                                                                                2020-11-27
                                                                                                Application Number
                                                                                                Indian CDSCO WC-0317A2
                                                                                                Status
                                                                                                 
                                                                                                Expired
                                                                                                2021-06-07
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                                                                                                2020-11-27
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                                                                                                  Granisetron

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                                                                                                  Caution WC

                                                                                                  Indian CDSCO WC-0317A2
                                                                                                  Expired
                                                                                                  Granisetron USP/EP
                                                                                                  2020-11-27
                                                                                                  Application Number
                                                                                                  Indian CDSCO WC-0317A2
                                                                                                  Status
                                                                                                   
                                                                                                  Expired
                                                                                                  2021-06-07
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                                                                                                  Granisetron USP/EP
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                                                                                                    Levocetirizine Dihydrochloride

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                                                                                                    Written Confirmation

                                                                                                    Caution WC

                                                                                                    Indian CDSCO WC-0317A2
                                                                                                    Expired
                                                                                                    levocetrizine Dihydrochloride USP
                                                                                                    2020-11-27
                                                                                                    Application Number
                                                                                                    Indian CDSCO WC-0317A2
                                                                                                    Status
                                                                                                     
                                                                                                    Expired
                                                                                                    2021-06-07
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                                                                                                    levocetrizine Dihydrochloride USP
                                                                                                    Issue/Submission Date
                                                                                                    2020-11-27
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                                                                                                      Levofloxacin Hemihydrate

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                                                                                                      Indian CDSCO WC-0317A2
                                                                                                      Expired
                                                                                                      Levofloxacin Hemihydrate USP
                                                                                                      2020-11-27
                                                                                                      Application Number
                                                                                                      Indian CDSCO WC-0317A2
                                                                                                      Status
                                                                                                       
                                                                                                      Expired
                                                                                                      2021-06-07
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                                                                                                      Levofloxacin Hemihydrate USP
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                                                                                                        Modafinil

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                                                                                                        Indian CDSCO WC-0317A2
                                                                                                        Expired
                                                                                                        Modafinil USP/EP
                                                                                                        2020-11-27
                                                                                                        Application Number
                                                                                                        Indian CDSCO WC-0317A2
                                                                                                        Status
                                                                                                         
                                                                                                        Expired
                                                                                                        2021-06-07
                                                                                                        Filing Details
                                                                                                        Modafinil USP/EP
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