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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Acebright Group

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    Acebright Group
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    Building 5, No. 1999 Zhangheng Road, High-Tech Park, Zhangjiang 201203
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    +86 21 607 53300
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    enquiries@pharmacompass.com
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      Sunitinib

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      USDMF

      Found USDMF

      36392
      Active
      SUNITINIB MALATE
      2021-10-12
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      305MF10101
      Sunitinib Malate at No. 77D & 116/1...
      2023-08-30
      Written Confirmation

      Found WC

      Indian CDSCO WC-0327n
      Valid
      Sunitinib Malate
      2021-09-01
      Application Number
      36392
      305MF10101
      Indian CDSCO WC-0327n
      Status
      Active
      Fees Unpaid
      Reviewed
       
      Valid
      2024-07-15
      Filing Details
      SUNITINIB MALATE
      Sunitinib Malate at No. 77D & 116/1...
      Sunitinib Malate
      Issue/Submission Date
      2021-10-12
      2023-08-30
      2021-09-01
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      Capecitabine

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      USDMF

      Found USDMF

      25054
      Active
      CAPECITABINE USP [DRUG SUBSTANCE (N...
      2011-06-14
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      231MF10064
      Capecitabine at No. 77D & 116/117, ...
      2019-03-05
      Written Confirmation

      Close WC

      Application Number
      25054
      231MF10064
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      CAPECITABINE USP [DRUG SUBSTANCE (N...
      Capecitabine at No. 77D & 116/117, ...
      Issue/Submission Date
      2011-06-14
      2019-03-05
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        Capecitabine

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        USDMF

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        CEP/COS

        Found CEP/COS

        R1-CEP 2013-309 - Rev 03
        Valid
        Capecitabine
        2021-09-08
        Japanese DMF

        Close JDMF

        Written Confirmation

        Found WC

        Indian CDSCO WC-0327n
        Valid
        Capecitabin USP/EP/IP/IH
        2021-09-01
        Application Number
        R1-CEP 2013-309 - Rev 03
        Indian CDSCO WC-0327n
        Status
        Valid
         
        Valid
        2024-07-15
        Filing Details
        Capecitabine
        Capecitabin USP/EP/IP/IH
        Issue/Submission Date
        2021-09-08
        2021-09-01
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          Dasatinib

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          USDMF

          Found USDMF

          35990
          Active
          DASATINIB [DRUG SUBSTANCE (NON-STER...
          2021-06-02
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Found WC

          Indian CDSCO WC-0327n
          Valid
          Dasatinib IH
          2021-09-01
          Application Number
          35990
          Indian CDSCO WC-0327n
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Valid
          2024-07-15
          Filing Details
          DASATINIB [DRUG SUBSTANCE (NON-STER...
          Dasatinib IH
          Issue/Submission Date
          2021-06-02
          2021-09-01
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            Erlotinib Hydrochloride

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            USDMF

            Found USDMF

            36007
            Active
            ERLOTINIB HYDROCHLORIDE [DRUG SUBST...
            2021-06-04
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Found WC

            Indian CDSCO WC-0327n
            Valid
            Erlotinib Hydrochloride IH
            2021-09-01
            Application Number
            36007
            Indian CDSCO WC-0327n
            Status
            Active
            Fees Unpaid
            Reviewed
             
            Valid
            2024-07-15
            Filing Details
            ERLOTINIB HYDROCHLORIDE [DRUG SUBST...
            Erlotinib Hydrochloride IH
            Issue/Submission Date
            2021-06-04
            2021-09-01
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              Imatinib Mesylate

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              USDMF

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              CEP/COS

              Found CEP/COS

              CEP 2023-221 - Rev 00
              Valid
              Imatinib mesilate, Process 2
              2023-10-30
              Japanese DMF

              Close JDMF

              Written Confirmation

              Found WC

              Indian CDSCO WC-0327n
              Valid
              Imatinib Mesilate IH
              2021-09-01
              Application Number
              CEP 2023-221 - Rev 00
              Indian CDSCO WC-0327n
              Status
              Valid
               
              Valid
              2024-07-15
              Filing Details
              Imatinib mesilate, Process 2
              Imatinib Mesilate IH
              Issue/Submission Date
              2023-10-30
              2021-09-01
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                Pazopanib Hydrochloride

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                USDMF

                Found USDMF

                33054
                Active
                PAZOPANIB HCL (NON-STERILE DRUG SUB...
                2018-07-28
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Found WC

                Indian CDSCO WC-0327n
                Valid
                Pazopanib HCl IH
                2021-09-01
                Application Number
                33054
                Indian CDSCO WC-0327n
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Valid
                2024-07-15
                Filing Details
                PAZOPANIB HCL (NON-STERILE DRUG SUB...
                Pazopanib HCl IH
                Issue/Submission Date
                2018-07-28
                2021-09-01
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                Erlotinib Hydrochloride

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                USDMF

                Found USDMF

                33226
                Active
                ERLOTINIB HYDROCHLORIDE (NON-STERIL...
                2018-09-29
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Caution WC

                Indian CDSCO WC-0327
                Expired
                Erlotinib Hydrochloride IH
                2019-01-14
                Application Number
                33226
                Indian CDSCO WC-0327
                Status
                Active
                Fees Paid
                N/A
                 
                Expired
                2021-07-15
                Filing Details
                ERLOTINIB HYDROCHLORIDE (NON-STERIL...
                Erlotinib Hydrochloride IH
                Issue/Submission Date
                2018-09-29
                2019-01-14
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                  Abiraterone Acetate

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                  USDMF

                  Found USDMF

                  36670
                  Active
                  ABIRATERONE ACETATE
                  2022-01-06
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  36670
                  Status
                  Active
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  ABIRATERONE ACETATE
                  Issue/Submission Date
                  2022-01-06
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                  Atazanavir Sulfate

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                  USDMF

                  Found USDMF

                  28952
                  Active
                  ATAZANAVIR SULPHATE [DRUG SUBSTANCE...
                  2014-12-23
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  28952
                  Status
                  Active
                  Fees Paid
                  N/A
                   
                  Filing Details
                  ATAZANAVIR SULPHATE [DRUG SUBSTANCE...
                  Issue/Submission Date
                  2014-12-23
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                    Atazanavir Sulfate

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                    USDMF

                    Found USDMF

                    26672
                    Active
                    ATAZANAVIR SULFATE
                    2012-11-20
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    26672
                    Status
                    Active
                    Fees Paid
                    N/A
                     
                    Filing Details
                    ATAZANAVIR SULFATE
                    Issue/Submission Date
                    2012-11-20
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                      Atovaquone

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                      USDMF

                      Found USDMF

                      25305
                      Active
                      ATOVAQUONE
                      2011-09-13
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      25305
                      Status
                      Active
                      Fees Paid
                      N/A
                       
                      Filing Details
                      ATOVAQUONE
                      Issue/Submission Date
                      2011-09-13
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                      Bictegravir

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                      USDMF

                      Found USDMF

                      34984
                      Active
                      2,5-PYRIDINEDICARBOXYLIC ACID,1-(2,...
                      2020-06-28
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      34984
                      Status
                      Active
                      Fees Paid
                      N/A
                       
                      Filing Details
                      2,5-PYRIDINEDICARBOXYLIC ACID,1-(2,...
                      Issue/Submission Date
                      2020-06-28
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                      Cabotegravir Sodium

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                      USDMF

                      Found USDMF

                      37452
                      Active
                      CABOTEGRAVIR SODIUM
                      2022-09-14
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      37452
                      Status
                      Active
                      Fees Paid
                      N/A
                       
                      Filing Details
                      CABOTEGRAVIR SODIUM
                      Issue/Submission Date
                      2022-09-14
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                      Canagliflozin

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                      USDMF

                      Found USDMF

                      30366
                      Active
                      CANAGLIFLOZIN
                      2015-12-31
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      30366
                      Status
                      Active
                      Fees Paid
                      N/A
                       
                      Filing Details
                      CANAGLIFLOZIN
                      Issue/Submission Date
                      2015-12-31
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                      Dabigatran Etexilate Mesylate

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                      USDMF

                      Found USDMF

                      35360
                      Active
                      DABIGATRAN ETEXILATE MESYLATE [DRUG...
                      2020-10-31
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      35360
                      Status
                      Active
                      Fees Paid
                      N/A
                       
                      Filing Details
                      DABIGATRAN ETEXILATE MESYLATE [DRUG...
                      Issue/Submission Date
                      2020-10-31
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                        Dasatinib

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                        USDMF

                        Found USDMF

                        37942
                        Active
                        DASATINIB
                        2023-01-16
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        37942
                        Status
                        Active
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        DASATINIB
                        Issue/Submission Date
                        2023-01-16
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                        Dolutegravir Sodium

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                        USDMF

                        Found USDMF

                        30365
                        Active
                        DOLUTEGRAVIR SODIUM
                        2016-02-03
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        30365
                        Status
                        Active
                        Fees Paid
                        Reviewed
                         
                        Filing Details
                        DOLUTEGRAVIR SODIUM
                        Issue/Submission Date
                        2016-02-03
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                        Edoxaban Tosylate

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                        USDMF

                        Found USDMF

                        36062
                        Active
                        EDOXABAN TOSYLATE MONOHYDRATE
                        2021-07-09
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        36062
                        Status
                        Active
                        Fees Paid
                        Reviewed
                         
                        Filing Details
                        EDOXABAN TOSYLATE MONOHYDRATE
                        Issue/Submission Date
                        2021-07-09
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                        Efavirenz

                        PDF Supplier PDF
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                        USDMF

                        Found USDMF

                        24847
                        Active
                        EFAVIRENZ [DRUG SUBSTANCE (NON-STER...
                        2011-04-08
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        24847
                        Status
                        Active
                        Fees Paid
                        Reviewed
                         
                        Filing Details
                        EFAVIRENZ [DRUG SUBSTANCE (NON-STER...
                        Issue/Submission Date
                        2011-04-08
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                          Efavirenz

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                          USDMF

                          Found USDMF

                          23271
                          Active
                          EFAVIRENZ USP
                          2009-11-04
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          23271
                          Status
                          Active
                          Fees Paid
                          Reviewed
                           
                          Filing Details
                          EFAVIRENZ USP
                          Issue/Submission Date
                          2009-11-04
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                          Elagolix Sodium

                          PDF Supplier PDF
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                          USDMF

                          Found USDMF

                          36823
                          Active
                          ELAGOLIX SODIUM
                          2022-03-09
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          36823
                          Status
                          Active
                          Fees Paid
                          N/A
                           
                          Filing Details
                          ELAGOLIX SODIUM
                          Issue/Submission Date
                          2022-03-09
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                          Elvitegravir

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                          USDMF

                          Found USDMF

                          32456
                          Active
                          ELVITEGRAVIR
                          2017-12-20
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          32456
                          Status
                          Active
                          Fees Paid
                          N/A
                           
                          Filing Details
                          ELVITEGRAVIR
                          Issue/Submission Date
                          2017-12-20
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                            Emtricitabine

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                            USDMF

                            Found USDMF

                            25617
                            Active
                            EMTRICITABINE
                            2011-12-19
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            25617
                            Status
                            Active
                            Fees Paid
                            Reviewed
                             
                            Filing Details
                            EMTRICITABINE
                            Issue/Submission Date
                            2011-12-19
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                              Enzalutamide

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                              USDMF

                              Found USDMF

                              37904
                              Active
                              ENZALUTAMIDE
                              2022-12-22
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              37904
                              Status
                              Active
                              Fees Unpaid
                              N/A
                               
                              Filing Details
                              ENZALUTAMIDE
                              Issue/Submission Date
                              2022-12-22
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                              Imatinib Mesylate

                              PDF Supplier PDF
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                              USDMF

                              Found USDMF

                              26322
                              Active
                              IMATINIB MESYLATE [DRUG SUBSTANCE(N...
                              2012-08-17
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              26322
                              Status
                              Active
                              Fees Paid
                              N/A
                               
                              Filing Details
                              IMATINIB MESYLATE [DRUG SUBSTANCE(N...
                              Issue/Submission Date
                              2012-08-17
                              ASK
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                              • FDA
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                              Imatinib Mesylate

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                              USDMF

                              Found USDMF

                              26424
                              Active
                              IMATINIB MESYLATE A-FORM [DRUG SUBS...
                              2012-09-11
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              26424
                              Status
                              Active
                              Fees Paid
                              N/A
                               
                              Filing Details
                              IMATINIB MESYLATE A-FORM [DRUG SUBS...
                              Issue/Submission Date
                              2012-09-11
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                                Imatinib Mesylate

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                                USDMF

                                Close USDMF

                                CEP/COS

                                Found CEP/COS

                                R0-CEP 2018-262 - Rev 01
                                Valid
                                Imatinib mesilate
                                2022-10-24
                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                R0-CEP 2018-262 - Rev 01
                                Status
                                Valid
                                 
                                Filing Details
                                Imatinib mesilate
                                Issue/Submission Date
                                2022-10-24
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                                  Lamivudine

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                                  USDMF

                                  Found USDMF

                                  21278
                                  Active
                                  LAMIVUDINE USP
                                  2008-01-22
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  21278
                                  Status
                                  Active
                                  Fees Paid
                                  Reviewed
                                   
                                  Filing Details
                                  LAMIVUDINE USP
                                  Issue/Submission Date
                                  2008-01-22
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                                  Lamivudine

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                                  USDMF

                                  Close USDMF

                                  CEP/COS

                                  Found CEP/COS

                                  R1-CEP 2015-272 - Rev 00
                                  Valid
                                  Lamivudine
                                  2021-11-25
                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  R1-CEP 2015-272 - Rev 00
                                  Status
                                  Valid
                                   
                                  Filing Details
                                  Lamivudine
                                  Issue/Submission Date
                                  2021-11-25
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                                  • FDA
                                  • EDQM
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                                  Lopinavir

                                  PDF Supplier PDF
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                                  USDMF

                                  Found USDMF

                                  28244
                                  Active
                                  LOPINAVIR [DRUG SUBSTANCE (NON-STER...
                                  2014-04-28
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  28244
                                  Status
                                  Active
                                  Fees Paid
                                  N/A
                                   
                                  Filing Details
                                  LOPINAVIR [DRUG SUBSTANCE (NON-STER...
                                  Issue/Submission Date
                                  2014-04-28
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                                  Lopinavir

                                  PDF Supplier PDF
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                                  USDMF

                                  Found USDMF

                                  30154
                                  Active
                                  LOPINAVIR
                                  2015-12-08
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  30154
                                  Status
                                  Active
                                  Fees Paid
                                  N/A
                                   
                                  Filing Details
                                  LOPINAVIR
                                  Issue/Submission Date
                                  2015-12-08
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                                  Lopinavir

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                                  USDMF

                                  Found USDMF

                                  34144
                                  Active
                                  LOPINAVIR HYDRATE
                                  2019-09-16
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  34144
                                  Status
                                  Active
                                  Fees Paid
                                  N/A
                                   
                                  Filing Details
                                  LOPINAVIR HYDRATE
                                  Issue/Submission Date
                                  2019-09-16
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                                    Lumefantrine

                                    PDF Supplier PDF
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                                    USDMF

                                    Found USDMF

                                    26766
                                    Active
                                    LUMEFANTRINE
                                    2012-12-20
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    26766
                                    Status
                                    Active
                                    Fees Paid
                                    N/A
                                     
                                    Filing Details
                                    LUMEFANTRINE
                                    Issue/Submission Date
                                    2012-12-20
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                                      Nevirapine

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                                      USDMF

                                      Found USDMF

                                      21280
                                      Active
                                      NEVIRAPINE USP
                                      2008-01-22
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      21280
                                      Status
                                      Active
                                      Fees Paid
                                      Reviewed
                                       
                                      Filing Details
                                      NEVIRAPINE USP
                                      Issue/Submission Date
                                      2008-01-22
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                                      Oseltamivir Phosphate

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                                      USDMF

                                      Found USDMF

                                      35514
                                      Active
                                      OSELTAMIVIR PHOSPHATE
                                      2021-01-15
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      35514
                                      Status
                                      Active
                                      Fees Paid
                                      Reviewed
                                       
                                      Filing Details
                                      OSELTAMIVIR PHOSPHATE
                                      Issue/Submission Date
                                      2021-01-15
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                                        Palbociclib

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                                        USDMF

                                        Found USDMF

                                        33055
                                        Active
                                        PALBOCICLIB (NON-STERILE DRUG SUBST...
                                        2018-08-14
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        33055
                                        Status
                                        Active
                                        Fees Unpaid
                                        Reviewed
                                         
                                        Filing Details
                                        PALBOCICLIB (NON-STERILE DRUG SUBST...
                                        Issue/Submission Date
                                        2018-08-14
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                                        Pemetrexed Disodium

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                                        USDMF

                                        Found USDMF

                                        32639
                                        Active
                                        PEMETREXED DISODIUM HEMIPENTA HYDRA...
                                        2018-02-28
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        32639
                                        Status
                                        Active
                                        Fees Paid
                                        Reviewed
                                         
                                        Filing Details
                                        PEMETREXED DISODIUM HEMIPENTA HYDRA...
                                        Issue/Submission Date
                                        2018-02-28
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                                          Praziquantel

                                          PDF Supplier PDF
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                                          USDMF

                                          Found USDMF

                                          26837
                                          Active
                                          PRAZIQUANTEL
                                          2013-01-14
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          26837
                                          Status
                                          Active
                                          Fees Paid
                                          N/A
                                           
                                          Filing Details
                                          PRAZIQUANTEL
                                          Issue/Submission Date
                                          2013-01-14
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                                          Praziquantel

                                          PDF Supplier PDF
                                          URL Supplier Web Content
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                                          See Less

                                          USDMF

                                          Close USDMF

                                          CEP/COS

                                          Found CEP/COS

                                          R1-CEP 2014-144 - Rev 01
                                          Valid
                                          Praziquantel
                                          2021-12-07
                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          R1-CEP 2014-144 - Rev 01
                                          Status
                                          Valid
                                           
                                          Filing Details
                                          Praziquantel
                                          Issue/Submission Date
                                          2021-12-07
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                                            Ritonavir

                                            PDF Supplier PDF
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                                            USDMF

                                            Found USDMF

                                            24383
                                            Active
                                            RITONAVIR USP
                                            2010-12-02
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            24383
                                            Status
                                            Active
                                            Fees Paid
                                            Reviewed
                                             
                                            Filing Details
                                            RITONAVIR USP
                                            Issue/Submission Date
                                            2010-12-02
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                                            Ritonavir

                                            PDF Supplier PDF
                                            URL Supplier Web Content
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                                            USDMF

                                            Close USDMF

                                            CEP/COS

                                            Found CEP/COS

                                            R0-CEP 2020-416 - Rev 00
                                            Valid
                                            Ritonavir, Form-II
                                            2021-05-12
                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            R0-CEP 2020-416 - Rev 00
                                            Status
                                            Valid
                                             
                                            Filing Details
                                            Ritonavir, Form-II
                                            Issue/Submission Date
                                            2021-05-12
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                                            Ritonavir

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                                            USDMF

                                            Close USDMF

                                            CEP/COS

                                            Found CEP/COS

                                            CEP 2017-229 - Rev 02
                                            Valid
                                            Ritonavir
                                            2023-09-28
                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            CEP 2017-229 - Rev 02
                                            Status
                                            Valid
                                             
                                            Filing Details
                                            Ritonavir
                                            Issue/Submission Date
                                            2023-09-28
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                                              Rosuvastatin Calcium

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                                              USDMF

                                              Found USDMF

                                              27777
                                              Active
                                              ROSUVASTATIN CALCIUM
                                              2013-09-06
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              27777
                                              Status
                                              Active
                                              Fees Paid
                                              N/A
                                               
                                              Filing Details
                                              ROSUVASTATIN CALCIUM
                                              Issue/Submission Date
                                              2013-09-06
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                                              Tenofovir Alafenamide Fumarate

                                              PDF Supplier PDF
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                                              USDMF

                                              Found USDMF

                                              34906
                                              Active
                                              TENOFOVIR ALAFENAMIDE FUMARATE [DRU...
                                              2020-08-12
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              34906
                                              Status
                                              Active
                                              Fees Paid
                                              N/A
                                               
                                              Filing Details
                                              TENOFOVIR ALAFENAMIDE FUMARATE [DRU...
                                              Issue/Submission Date
                                              2020-08-12
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                                              Tenofovir Alafenamide Fumarate

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                                              USDMF

                                              Found USDMF

                                              31700
                                              Active
                                              TENOFOVIR ALAFENAMIDE FUMARATE
                                              2017-03-31
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              31700
                                              Status
                                              Active
                                              Fees Paid
                                              Reviewed
                                               
                                              Filing Details
                                              TENOFOVIR ALAFENAMIDE FUMARATE
                                              Issue/Submission Date
                                              2017-03-31
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                                              Tenofovir Disoproxil Fumarate

                                              PDF Supplier PDF
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                                              USDMF

                                              Found USDMF

                                              27143
                                              Active
                                              TENOFOVIR DISOPROXIL FUMARATE [DRUG...
                                              2013-05-08
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              27143
                                              Status
                                              Active
                                              Fees Paid
                                              Reviewed
                                               
                                              Filing Details
                                              TENOFOVIR DISOPROXIL FUMARATE [DRUG...
                                              Issue/Submission Date
                                              2013-05-08
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                                                Tenofovir Disoproxil Fumarate

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                                                USDMF

                                                Found USDMF

                                                25304
                                                Active
                                                TENOFOVIR DISOPROXIL FUMARATE
                                                2011-09-13
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                25304
                                                Status
                                                Active
                                                Fees Paid
                                                Reviewed
                                                 
                                                Filing Details
                                                TENOFOVIR DISOPROXIL FUMARATE
                                                Issue/Submission Date
                                                2011-09-13
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                                                  Zidovudine

                                                  PDF Supplier PDF
                                                  URL Supplier Web Content
                                                  See all info for this product

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                                                  USDMF

                                                  Found USDMF

                                                  21277
                                                  Active
                                                  ZIDOVUDINE USP
                                                  2008-01-22
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  21277
                                                  Status
                                                  Active
                                                  Fees Paid
                                                  Reviewed
                                                   
                                                  Filing Details
                                                  ZIDOVUDINE USP
                                                  Issue/Submission Date
                                                  2008-01-22
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                                                  Zidovudine

                                                  PDF Supplier PDF
                                                  URL Supplier Web Content
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                                                  USDMF

                                                  Close USDMF

                                                  CEP/COS

                                                  Found CEP/COS

                                                  R0-CEP 2021-015 - Rev 00
                                                  Valid
                                                  Zidovudine
                                                  2022-07-13
                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  R0-CEP 2021-015 - Rev 00
                                                  Status
                                                  Valid
                                                   
                                                  Filing Details
                                                  Zidovudine
                                                  Issue/Submission Date
                                                  2022-07-13
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