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      Amitriptyline Hydrochloride

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      USDMF

      Found USDMF

      33565
      Active
      AMITRIPTYLINE HYDROCHLORIDE USP
      2019-07-24
      CEP/COS

      Found CEP/COS

      R0-CEP 2019-227 - Rev 00
      Valid
      Amitriptyline hydrochloride
      2021-07-16
      Japanese DMF

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      Application Number
      33565
      R0-CEP 2019-227 - Rev 00
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      AMITRIPTYLINE HYDROCHLORIDE USP
      Amitriptyline hydrochloride
      Issue/Submission Date
      2019-07-24
      2021-07-16
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        Atorvastatin

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        USDMF

        Found USDMF

        34844
        Active
        ATORVASTATIN CALCIUM USP
        2020-06-05
        CEP/COS

        Found CEP/COS

        CEP 2022-262 - Rev 00
        Valid
        Atorvastatin calcium, Trihydrate
        2024-02-16
        Japanese DMF

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        Application Number
        34844
        CEP 2022-262 - Rev 00
        Status
        Active
        Fees Unpaid
        Reviewed
        Valid
         
        Filing Details
        ATORVASTATIN CALCIUM USP
        Atorvastatin calcium, Trihydrate
        Issue/Submission Date
        2020-06-05
        2024-02-16
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          Clomipramine Hydrochloride

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          USDMF

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          34935
          Active
          CLOMIPRAMINE HYDROCHLORIDE USP
          2020-07-30
          CEP/COS

          Found CEP/COS

          R0-CEP 2020-310 - Rev 00
          Valid
          Clomipramine Hydrochloride
          2022-10-24
          Japanese DMF

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          Application Number
          34935
          R0-CEP 2020-310 - Rev 00
          Status
          Active
          Fees Unpaid
          Reviewed
          Valid
           
          Filing Details
          CLOMIPRAMINE HYDROCHLORIDE USP
          Clomipramine Hydrochloride
          Issue/Submission Date
          2020-07-30
          2022-10-24
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            Haloperidol

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            USDMF

            Found USDMF

            34190
            Active
            HALOPERIDOL USP
            2019-11-22
            CEP/COS

            Found CEP/COS

            CEP 2020-026 - Rev 01
            Valid
            Haloperidol
            2024-02-22
            Japanese DMF

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            Application Number
            34190
            CEP 2020-026 - Rev 01
            Status
            Active
            Fees Unpaid
            Reviewed
            Valid
             
            Filing Details
            HALOPERIDOL USP
            Haloperidol
            Issue/Submission Date
            2019-11-22
            2024-02-22
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              Haloperidol Decanoate

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              USDMF

              Found USDMF

              34353
              Active
              HALOPERIDOL DECANOATE USP
              2020-02-26
              CEP/COS

              Found CEP/COS

              R0-CEP 2020-080 - Rev 00
              Valid
              Haloperidol decanoate
              2022-05-20
              Japanese DMF

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              Application Number
              34353
              R0-CEP 2020-080 - Rev 00
              Status
              Active
              Fees Unpaid
              Reviewed
              Valid
               
              Filing Details
              HALOPERIDOL DECANOATE USP
              Haloperidol decanoate
              Issue/Submission Date
              2020-02-26
              2022-05-20
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                Nitrofurantoin

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                USDMF

                Found USDMF

                33351
                Active
                NITROFURANTOIN MONOHYDRATE USP
                2018-12-28
                CEP/COS

                Found CEP/COS

                R0-CEP 2021-371 - Rev 00
                Valid
                Nitrofurantoin, Macrocrystals (Proc...
                2021-12-10
                Japanese DMF

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                Application Number
                33351
                R0-CEP 2021-371 - Rev 00
                Status
                Active
                Fees Unpaid
                Reviewed
                Valid
                 
                Filing Details
                NITROFURANTOIN MONOHYDRATE USP
                Nitrofurantoin, Macrocrystals (Proc...
                Issue/Submission Date
                2018-12-28
                2021-12-10
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                  Nitrofurantoin

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                  USDMF

                  Found USDMF

                  33523
                  Active
                  NITROFURANTOIN MACROCRYSTALS USP
                  2019-02-23
                  CEP/COS

                  Found CEP/COS

                  CEP 2019-092 - Rev 02
                  Valid
                  Nitrofurantoin, Macrocrystals
                  2023-10-12
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

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                  Application Number
                  33523
                  CEP 2019-092 - Rev 02
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                  Valid
                   
                  Filing Details
                  NITROFURANTOIN MACROCRYSTALS USP
                  Nitrofurantoin, Macrocrystals
                  Issue/Submission Date
                  2019-02-23
                  2023-10-12
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                    Pantoprazole Sodium

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                    USDMF

                    Found USDMF

                    35357
                    Active
                    PANTOPRAZOLE SODIUM USP
                    2020-12-07
                    CEP/COS

                    Found CEP/COS

                    R0-CEP 2021-073 - Rev 00
                    Valid
                    Pantoprazole sodium sesquihydrate
                    2022-11-14
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

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                    Application Number
                    35357
                    R0-CEP 2021-073 - Rev 00
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                    Valid
                     
                    Filing Details
                    PANTOPRAZOLE SODIUM USP
                    Pantoprazole sodium sesquihydrate
                    Issue/Submission Date
                    2020-12-07
                    2022-11-14
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                      Propranolol Hydrochloride

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                      USDMF

                      Found USDMF

                      35635
                      Active
                      PROPRANOLOL HYDROCHLORIDE USP
                      2021-03-05
                      CEP/COS

                      Found CEP/COS

                      R0-CEP 2021-104 - Rev 00
                      Valid
                      Propranolol hydrochloride
                      2023-08-30
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

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                      Application Number
                      35635
                      R0-CEP 2021-104 - Rev 00
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                      Valid
                       
                      Filing Details
                      PROPRANOLOL HYDROCHLORIDE USP
                      Propranolol hydrochloride
                      Issue/Submission Date
                      2021-03-05
                      2023-08-30
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                        Rosuvastatin Calcium

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                        USDMF

                        Found USDMF

                        36493
                        Active
                        ROSUVASTATIN CALCIUM USP
                        2021-12-22
                        CEP/COS

                        Found CEP/COS

                        R0-CEP 2022-060 - Rev 00
                        Valid
                        Rosuvastatin calcium, Micronised
                        2023-06-26
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

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                        Application Number
                        36493
                        R0-CEP 2022-060 - Rev 00
                        Status
                        Active
                        Fees Unpaid
                        Reviewed
                        Valid
                         
                        Filing Details
                        ROSUVASTATIN CALCIUM USP
                        Rosuvastatin calcium, Micronised
                        Issue/Submission Date
                        2021-12-22
                        2023-06-26
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                          Ticagrelor

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                          USDMF

                          Found USDMF

                          36711
                          Active
                          TICAGRELOR
                          2022-02-01
                          CEP/COS

                          Found CEP/COS

                          R0-CEP 2022-067 - Rev 00
                          Valid
                          Ticagrelor
                          2023-07-06
                          Japanese DMF

                          Close JDMF

                          Written Confirmation

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                          Application Number
                          36711
                          R0-CEP 2022-067 - Rev 00
                          Status
                          Active
                          Fees Unpaid
                          Reviewed
                          Valid
                           
                          Filing Details
                          TICAGRELOR
                          Ticagrelor
                          Issue/Submission Date
                          2022-02-01
                          2023-07-06
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                            Atorvastatin

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                            USDMF

                            Found USDMF

                            36365
                            Active
                            ATORVASTATIN CALCIUM USP (PROCESS I...
                            2021-09-30
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            36365
                            Status
                            Active
                            Fees Unpaid
                            N/A
                             
                            Filing Details
                            ATORVASTATIN CALCIUM USP (PROCESS I...
                            Issue/Submission Date
                            2021-09-30
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                              Baclofen

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                              USDMF

                              Found USDMF

                              37011
                              Active
                              BACLOFEN USP
                              2022-04-27
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

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                              Application Number
                              37011
                              Status
                              Active
                              Fees Unpaid
                              Reviewed
                               
                              Filing Details
                              BACLOFEN USP
                              Issue/Submission Date
                              2022-04-27
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                                Clozapine

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                                USDMF

                                Found USDMF

                                37540
                                Active
                                CLOZAPINE USP
                                2023-02-01
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

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                                Application Number
                                37540
                                Status
                                Active
                                Fees Unpaid
                                N/A
                                 
                                Filing Details
                                CLOZAPINE USP
                                Issue/Submission Date
                                2023-02-01
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                                  Pantoprazole Sodium

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                                  USDMF

                                  Found USDMF

                                  36393
                                  Active
                                  PANTOPRAZOLE SODIUM USP (PROCESS II...
                                  2021-10-18
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  36393
                                  Status
                                  Active
                                  Fees Unpaid
                                  N/A
                                   
                                  Filing Details
                                  PANTOPRAZOLE SODIUM USP (PROCESS II...
                                  Issue/Submission Date
                                  2021-10-18
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                                    Ranolazine

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                                    USDMF

                                    Found USDMF

                                    34571
                                    Active
                                    RANOLAZINE
                                    2020-03-31
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

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                                    Application Number
                                    34571
                                    Status
                                    Active
                                    Fees Unpaid
                                    Reviewed
                                     
                                    Filing Details
                                    RANOLAZINE
                                    Issue/Submission Date
                                    2020-03-31
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                                      Revefenacin

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                                      USDMF

                                      Found USDMF

                                      36771
                                      Active
                                      REVEFENACIN
                                      2022-02-18
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      36771
                                      Status
                                      Active
                                      Fees Unpaid
                                      Reviewed
                                       
                                      Filing Details
                                      REVEFENACIN
                                      Issue/Submission Date
                                      2022-02-18
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                                        Sacubitril Sodium

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                                        USDMF

                                        Found USDMF

                                        36204
                                        Active
                                        SACUBITRIL SODIUM
                                        2021-10-12
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

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                                        Application Number
                                        36204
                                        Status
                                        Active
                                        Fees Unpaid
                                        N/A
                                         
                                        Filing Details
                                        SACUBITRIL SODIUM
                                        Issue/Submission Date
                                        2021-10-12
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                                          Sacubitril-Valsartan

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                                          USDMF

                                          Found USDMF

                                          36637
                                          Active
                                          SACUBITRIL VALSARTAN TRISODIUM (AMO...
                                          2022-01-17
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

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                                          Written Confirmation

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                                          Application Number
                                          36637
                                          Status
                                          Active
                                          Fees Unpaid
                                          N/A
                                           
                                          Filing Details
                                          SACUBITRIL VALSARTAN TRISODIUM (AMO...
                                          Issue/Submission Date
                                          2022-01-17
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                                            Sitagliptin Phosphate

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                                            USDMF

                                            Found USDMF

                                            35702
                                            Active
                                            SITAGLIPTIN PHOSPHATE
                                            2021-03-31
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            35702
                                            Status
                                            Active
                                            Fees Unpaid
                                            Reviewed
                                             
                                            Filing Details
                                            SITAGLIPTIN PHOSPHATE
                                            Issue/Submission Date
                                            2021-03-31
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                                              Succinylcholine Chloride

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                                              USDMF

                                              Found USDMF

                                              37245
                                              Active
                                              SUCCINYLCHOLINE CHLORIDE USP
                                              2022-07-25
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

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                                              Application Number
                                              37245
                                              Status
                                              Active
                                              Fees Unpaid
                                              Reviewed
                                               
                                              Filing Details
                                              SUCCINYLCHOLINE CHLORIDE USP
                                              Issue/Submission Date
                                              2022-07-25
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                                                Sugammadex Sodium

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                                                USDMF

                                                Found USDMF

                                                33864
                                                Active
                                                SUGAMMADEX SODIUM
                                                2019-07-18
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

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                                                Application Number
                                                33864
                                                Status
                                                Active
                                                Fees Unpaid
                                                Reviewed
                                                 
                                                Filing Details
                                                SUGAMMADEX SODIUM
                                                Issue/Submission Date
                                                2019-07-18
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                                                  Telmisartan

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                                                  USDMF

                                                  Found USDMF

                                                  36807
                                                  Active
                                                  TELMISARTAN USP
                                                  2022-03-23
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  36807
                                                  Status
                                                  Active
                                                  Fees Unpaid
                                                  Reviewed
                                                   
                                                  Filing Details
                                                  TELMISARTAN USP
                                                  Issue/Submission Date
                                                  2022-03-23
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                                                    Valsartan

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                                                    USDMF

                                                    Found USDMF

                                                    36203
                                                    Active
                                                    VALSARTAN DISODIUM
                                                    2021-11-02
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    36203
                                                    Status
                                                    Active
                                                    Fees Unpaid
                                                    N/A
                                                     
                                                    Filing Details
                                                    VALSARTAN DISODIUM
                                                    Issue/Submission Date
                                                    2021-11-02
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                                                      Vildagliptin

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                                                      USDMF

                                                      Found USDMF

                                                      37291
                                                      Active
                                                      VILDAGLIPTIN
                                                      2022-07-02
                                                      CEP/COS

                                                      Close CEP/COS

                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Close WC

                                                      Application Number
                                                      37291
                                                      Status
                                                      Active
                                                      Fees Unpaid
                                                      N/A
                                                       
                                                      Filing Details
                                                      VILDAGLIPTIN
                                                      Issue/Submission Date
                                                      2022-07-02
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                                                        Brivaracetam

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                                                        USDMF

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                                                        CEP/COS

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                                                        Japanese DMF

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                                                        Written Confirmation

                                                        Close WC

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