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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Gedeon Richter

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    Gedeon Richter
    Hungary Flag
    Country
    Country
    Hungary
    Address
    Address
    1103, Gyömrői road 19-21,Budapest
    Telephone
    Telephone
    36 143 140 00
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.richter.hu/hu-HU/Pages/default.aspx
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      Drospirenone

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      USDMF

      Found USDMF

      17866
      Active
      DROSPIRENONE USP
      2004-12-03
      CEP/COS

      Found CEP/COS

      R1-CEP 2009-402 - Rev 00
      Valid
      Drospirenone
      2015-06-08
      Japanese DMF

      Found JDMF

      305MF10112
      Drospirenone at BUDAPEST, GYOMROI U...
      2023-09-26
      Written Confirmation

      Close WC

      Application Number
      17866
      R1-CEP 2009-402 - Rev 00
      305MF10112
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      DROSPIRENONE USP
      Drospirenone
      Drospirenone at BUDAPEST, GYOMROI U...
      Issue/Submission Date
      2004-12-03
      2015-06-08
      2023-09-26
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        Terbinafine Hydrochloride

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        USDMF

        Found USDMF

        16511
        Active
        TERBINAFINE HYDROCHLORIDE USP
        2003-03-26
        CEP/COS

        Found CEP/COS

        R1-CEP 2006-112 - Rev 02
        Valid
        Terbinafine hydrochloride
        2019-01-28
        Japanese DMF

        Found JDMF

        218MF10443
        Terbinafine hydrochloride at BUDAPE...
        2006-04-27
        Written Confirmation

        Close WC

        Application Number
        16511
        R1-CEP 2006-112 - Rev 02
        218MF10443
        Status
        Active
        Fees Unpaid
        N/A
        Valid
         
        Filing Details
        TERBINAFINE HYDROCHLORIDE USP
        Terbinafine hydrochloride
        Terbinafine hydrochloride at BUDAPE...
        Issue/Submission Date
        2003-03-26
        2019-01-28
        2006-04-27
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          Vinblastine Sulfate

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          USDMF

          Caution USDMF

          3499
          Inactive
          VINBLASTIN S04
          1979-04-05
          CEP/COS

          Found CEP/COS

          R1-CEP 2005-261 - Rev 00
          Valid
          Vinblastine Sulfate
          2011-11-04
          Japanese DMF

          Found JDMF

          220MF10116
          Vinblastine sulfate salt at BUDAPES...
          2008-04-28
          Written Confirmation

          Close WC

          Application Number
          3499
          R1-CEP 2005-261 - Rev 00
          220MF10116
          Status
          Inactive
          Fees Unpaid
          N/A
          Valid
           
          Filing Details
          VINBLASTIN S04
          Vinblastine Sulfate
          Vinblastine sulfate salt at BUDAPES...
          Issue/Submission Date
          1979-04-05
          2011-11-04
          2008-04-28
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            Vincristine Sulfate

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            USDMF

            Caution USDMF

            3507
            Inactive
            VINCRISTINE SULFATE
            1979-04-27
            CEP/COS

            Found CEP/COS

            R1-CEP 1998-006 - Rev 03
            Valid
            Vincristine sulfate
            2008-09-17
            Japanese DMF

            Found JDMF

            220MF10117
            Vincristine sulfate salt at BUDAPES...
            2008-04-28
            Written Confirmation

            Close WC

            Application Number
            3507
            R1-CEP 1998-006 - Rev 03
            220MF10117
            Status
            Inactive
            Fees Unpaid
            N/A
            Valid
             
            Filing Details
            VINCRISTINE SULFATE
            Vincristine sulfate
            Vincristine sulfate salt at BUDAPES...
            Issue/Submission Date
            1979-04-27
            2008-09-17
            2008-04-28
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              Desogestrel

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              USDMF

              Found USDMF

              12368
              Active
              DESOGESTREL
              1997-02-18
              CEP/COS

              Found CEP/COS

              R1-CEP 2006-174 - Rev 04
              Valid
              Desogestrel
              2022-02-18
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              12368
              R1-CEP 2006-174 - Rev 04
              Status
              Active
              Fees Unpaid
              N/A
              Valid
               
              Filing Details
              DESOGESTREL
              Desogestrel
              Issue/Submission Date
              1997-02-18
              2022-02-18
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                Estetrol

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                USDMF

                Found USDMF

                37136
                Active
                ESTETROL MONOHYDRATE
                2022-06-10
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Found JDMF

                305MF10111
                Estetrol hydrate at BUDAPEST, GYOMR...
                2023-09-26
                Written Confirmation

                Close WC

                Application Number
                37136
                305MF10111
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                ESTETROL MONOHYDRATE
                Estetrol hydrate at BUDAPEST, GYOMR...
                Issue/Submission Date
                2022-06-10
                2023-09-26
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                  Estradiol

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                  USDMF

                  Found USDMF

                  4066
                  Active
                  ESTRADIOL USP
                  1981-01-21
                  CEP/COS

                  Found CEP/COS

                  R1-CEP 1999-040 - Rev 04
                  Valid
                  Estradiol hemihydrate
                  2014-08-12
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  4066
                  R1-CEP 1999-040 - Rev 04
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                  Valid
                   
                  Filing Details
                  ESTRADIOL USP
                  Estradiol hemihydrate
                  Issue/Submission Date
                  1981-01-21
                  2014-08-12
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                    Ethinyl Estradiol

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                    USDMF

                    Found USDMF

                    5740
                    Active
                    ETHINYL ESTRADIOL USP
                    1985-02-27
                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2001-400 - Rev 02
                    Valid
                    Ethinylestradiol
                    2019-01-18
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    5740
                    R1-CEP 2001-400 - Rev 02
                    Status
                    Active
                    Fees Unpaid
                    N/A
                    Valid
                     
                    Filing Details
                    ETHINYL ESTRADIOL USP
                    Ethinylestradiol
                    Issue/Submission Date
                    1985-02-27
                    2019-01-18
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                      Famotidine

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                      USDMF

                      Found USDMF

                      11537
                      Active
                      FAMOTIDINE, USP
                      1995-06-05
                      CEP/COS

                      Found CEP/COS

                      R1-CEP 1999-054 - Rev 03
                      Valid
                      Famotidine
                      2022-02-18
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      11537
                      R1-CEP 1999-054 - Rev 03
                      Status
                      Active
                      Fees Unpaid
                      N/A
                      Valid
                       
                      Filing Details
                      FAMOTIDINE, USP
                      Famotidine
                      Issue/Submission Date
                      1995-06-05
                      2022-02-18
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                        Levonorgestrel

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                        USDMF

                        Found USDMF

                        8806
                        Active
                        LEVONORGESTREL, USP
                        1990-10-30
                        CEP/COS

                        Found CEP/COS

                        R1-CEP 1999-141 - Rev 04
                        Valid
                        Levonorgestrel
                        2021-12-20
                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        8806
                        R1-CEP 1999-141 - Rev 04
                        Status
                        Active
                        Fees Unpaid
                        N/A
                        Valid
                         
                        Filing Details
                        LEVONORGESTREL, USP
                        Levonorgestrel
                        Issue/Submission Date
                        1990-10-30
                        2021-12-20
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                          Lisinopril

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                          USDMF

                          Caution USDMF

                          12912
                          Inactive
                          LISINOPRIL
                          1998-01-26
                          CEP/COS

                          Caution CEP/COS

                          R1-CEP 1999-051 - Rev 03
                          Withdrawn by Holder
                          Lisinopril dihydrate
                          2011-03-23
                          Japanese DMF

                          Found JDMF

                          219MF10198
                          LISINOPRIL DIHYDRATE at Budapest, G...
                          2007-06-08
                          Written Confirmation

                          Close WC

                          Application Number
                          12912
                          R1-CEP 1999-051 - Rev 03
                          219MF10198
                          Status
                          Inactive
                          Fees Unpaid
                          N/A
                          Withdrawn by Holder
                           
                          Filing Details
                          LISINOPRIL
                          Lisinopril dihydrate
                          LISINOPRIL DIHYDRATE at Budapest, G...
                          Issue/Submission Date
                          1998-01-26
                          2011-03-23
                          2007-06-08
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                            Spironolactone

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                            USDMF

                            Found USDMF

                            14077
                            Active
                            SPIRONOLACTONE USP
                            1999-03-29
                            CEP/COS

                            Found CEP/COS

                            R1-CEP 2000-005 - Rev 05
                            Valid
                            Spironolactone, Micronised
                            2019-07-31
                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            14077
                            R1-CEP 2000-005 - Rev 05
                            Status
                            Active
                            Fees Unpaid
                            N/A
                            Valid
                             
                            Filing Details
                            SPIRONOLACTONE USP
                            Spironolactone, Micronised
                            Issue/Submission Date
                            1999-03-29
                            2019-07-31
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                              Amlodipine Besylate

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                              USDMF

                              Caution USDMF

                              17584
                              Inactive
                              AMLODIPINE BESYLATE
                              2004-08-02
                              CEP/COS

                              Found CEP/COS

                              R1-CEP 2001-322 - Rev 03
                              Valid
                              Amlodipine besilate
                              2022-03-23
                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              17584
                              R1-CEP 2001-322 - Rev 03
                              Status
                              Inactive
                              Fees Unpaid
                              N/A
                              Valid
                               
                              Filing Details
                              AMLODIPINE BESYLATE
                              Amlodipine besilate
                              Issue/Submission Date
                              2004-08-02
                              2022-03-23
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                                Dienogest

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                                USDMF

                                Caution USDMF

                                24479
                                Inactive
                                DIENOGEST
                                2010-12-21
                                CEP/COS

                                Found CEP/COS

                                R0-CEP 2020-023 - Rev 00
                                Valid
                                Dienogest, Micronised
                                2022-05-03
                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                24479
                                R0-CEP 2020-023 - Rev 00
                                Status
                                Inactive
                                Fees Unpaid
                                N/A
                                Valid
                                 
                                Filing Details
                                DIENOGEST
                                Dienogest, Micronised
                                Issue/Submission Date
                                2010-12-21
                                2022-05-03
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                                  Fluconazole

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                                  USDMF

                                  Caution USDMF

                                  15883
                                  Inactive
                                  FLUCONAZOLE
                                  2002-03-04
                                  CEP/COS

                                  Found CEP/COS

                                  R1-CEP 2010-265 - Rev 00
                                  Valid
                                  Fluconazole
                                  2017-01-11
                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  15883
                                  R1-CEP 2010-265 - Rev 00
                                  Status
                                  Inactive
                                  Fees Unpaid
                                  N/A
                                  Valid
                                   
                                  Filing Details
                                  FLUCONAZOLE
                                  Fluconazole
                                  Issue/Submission Date
                                  2002-03-04
                                  2017-01-11
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                                    Norgestimate

                                    PDF Supplier PDF
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                                    USDMF

                                    Caution USDMF

                                    5708
                                    Inactive
                                    NORGESTIMATE
                                    1985-01-21
                                    CEP/COS

                                    Found CEP/COS

                                    R1-CEP 2009-125 - Rev 01
                                    Valid
                                    Norgestimate
                                    2021-12-02
                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    5708
                                    R1-CEP 2009-125 - Rev 01
                                    Status
                                    Inactive
                                    Fees Unpaid
                                    N/A
                                    Valid
                                     
                                    Filing Details
                                    NORGESTIMATE
                                    Norgestimate
                                    Issue/Submission Date
                                    1985-01-21
                                    2021-12-02
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                                      Alendronate Sodium

                                      PDF Supplier PDF
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                                      USDMF

                                      Close USDMF

                                      CEP/COS

                                      Found CEP/COS

                                      R1-CEP 2004-095 - Rev 04
                                      Valid
                                      Sodium alendronate trihydrate, Mill...
                                      2020-08-19
                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      R1-CEP 2004-095 - Rev 04
                                      Status
                                      Valid
                                       
                                      Filing Details
                                      Sodium alendronate trihydrate, Mill...
                                      Issue/Submission Date
                                      2020-08-19
                                      ASK
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                                        Allylestrenol

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                                        USDMF

                                        Close USDMF

                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Found JDMF

                                        218MF10213
                                        Allylestrenol at BUDAPEST, GYOMROI ...
                                        2006-02-16
                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        218MF10213
                                        Status
                                         
                                        Filing Details
                                        Allylestrenol at BUDAPEST, GYOMROI ...
                                        Issue/Submission Date
                                        2006-02-16
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                                          Amlodipine Besylate

                                          PDF Supplier PDF
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                                          USDMF

                                          Close USDMF

                                          CEP/COS

                                          Found CEP/COS

                                          R1-CEP 2010-318 - Rev 01
                                          Valid
                                          Amlodipine besilate, RTML process
                                          2022-08-18
                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          R1-CEP 2010-318 - Rev 01
                                          Status
                                          Valid
                                           
                                          Filing Details
                                          Amlodipine besilate, RTML process
                                          Issue/Submission Date
                                          2022-08-18
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                                            Azelastine Hydrochloride

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                                            USDMF

                                            Found USDMF

                                            15361
                                            Active
                                            AZELASTINE HCL USP
                                            2001-03-29
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            15361
                                            Status
                                            Active
                                            Fees Unpaid
                                            Reviewed
                                             
                                            Filing Details
                                            AZELASTINE HCL USP
                                            Issue/Submission Date
                                            2001-03-29
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                                              Cariprazine Hydrochloride

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                                              USDMF

                                              Found USDMF

                                              26321
                                              Active
                                              CARIPRAZINE HYDROCHLORIDE
                                              2012-07-26
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              26321
                                              Status
                                              Active
                                              Fees Unpaid
                                              N/A
                                               
                                              Filing Details
                                              CARIPRAZINE HYDROCHLORIDE
                                              Issue/Submission Date
                                              2012-07-26
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                                                Cimetidine

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                                                USDMF

                                                Caution USDMF

                                                9637
                                                Inactive
                                                CIMETIDINE
                                                1992-04-09
                                                CEP/COS

                                                Caution CEP/COS

                                                R0-CEP 2000-153 - Rev 01
                                                Expired
                                                Cimetidine, Crystallised from ethan...
                                                2004-11-09
                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                9637
                                                R0-CEP 2000-153 - Rev 01
                                                Status
                                                Inactive
                                                Fees Unpaid
                                                N/A
                                                Expired
                                                 
                                                Filing Details
                                                CIMETIDINE
                                                Cimetidine, Crystallised from ethan...
                                                Issue/Submission Date
                                                1992-04-09
                                                2004-11-09
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                                                  Drospirenone

                                                  PDF Supplier PDF
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                                                  USDMF

                                                  Close USDMF

                                                  CEP/COS

                                                  Found CEP/COS

                                                  R0-CEP 2022-279 - Rev 00
                                                  Valid
                                                  Drospirenone, Process 2 micronized
                                                  2022-12-01
                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  R0-CEP 2022-279 - Rev 00
                                                  Status
                                                  Valid
                                                   
                                                  Filing Details
                                                  Drospirenone, Process 2 micronized
                                                  Issue/Submission Date
                                                  2022-12-01
                                                  ASK
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                                                    Drospirenone

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                                                    USDMF

                                                    Close USDMF

                                                    CEP/COS

                                                    Found CEP/COS

                                                    R0-CEP 2021-508 - Rev 00
                                                    Valid
                                                    Drospirenone, Process I
                                                    2022-05-30
                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    R0-CEP 2021-508 - Rev 00
                                                    Status
                                                    Valid
                                                     
                                                    Filing Details
                                                    Drospirenone, Process I
                                                    Issue/Submission Date
                                                    2022-05-30
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                                                      Drospirenone

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                                                      USDMF

                                                      Close USDMF

                                                      CEP/COS

                                                      Found CEP/COS

                                                      R0-CEP 2022-278 - Rev 01
                                                      Valid
                                                      Drospirenone, Process 2
                                                      2023-07-31
                                                      Japanese DMF

                                                      Close JDMF

                                                      Written Confirmation

                                                      Close WC

                                                      Application Number
                                                      R0-CEP 2022-278 - Rev 01
                                                      Status
                                                      Valid
                                                       
                                                      Filing Details
                                                      Drospirenone, Process 2
                                                      Issue/Submission Date
                                                      2023-07-31
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                                                        Enalapril Maleate

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                                                        USDMF

                                                        Caution USDMF

                                                        12939
                                                        Inactive
                                                        ENALAPRIL MALEATE
                                                        1998-04-08
                                                        CEP/COS

                                                        Caution CEP/COS

                                                        R1-CEP 2001-408 - Rev 03
                                                        Withdrawn by Holder
                                                        Enalapril maleate
                                                        2010-11-25
                                                        Japanese DMF

                                                        Close JDMF

                                                        Written Confirmation

                                                        Close WC

                                                        Application Number
                                                        12939
                                                        R1-CEP 2001-408 - Rev 03
                                                        Status
                                                        Inactive
                                                        Fees Unpaid
                                                        N/A
                                                        Withdrawn by Holder
                                                         
                                                        Filing Details
                                                        ENALAPRIL MALEATE
                                                        Enalapril maleate
                                                        Issue/Submission Date
                                                        1998-04-08
                                                        2010-11-25
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                                                          Etonogestrel

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                                                          USDMF

                                                          Found USDMF

                                                          11997
                                                          Active
                                                          ETONOGESTREL
                                                          1996-06-10
                                                          CEP/COS

                                                          Close CEP/COS

                                                          Japanese DMF

                                                          Close JDMF

                                                          Written Confirmation

                                                          Close WC

                                                          Application Number
                                                          11997
                                                          Status
                                                          Active
                                                          Fees Unpaid
                                                          Reviewed
                                                           
                                                          Filing Details
                                                          ETONOGESTREL
                                                          Issue/Submission Date
                                                          1996-06-10
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                                                            Flutamide

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                                                            USDMF

                                                            Caution USDMF

                                                            10497
                                                            Inactive
                                                            FLUTAMIDE
                                                            1993-09-24
                                                            CEP/COS

                                                            Caution CEP/COS

                                                            R1-CEP 2004-282 - Rev 01
                                                            Withdrawn by Holder
                                                            Flutamide
                                                            2011-12-15
                                                            Japanese DMF

                                                            Close JDMF

                                                            Written Confirmation

                                                            Close WC

                                                            Application Number
                                                            10497
                                                            R1-CEP 2004-282 - Rev 01
                                                            Status
                                                            Inactive
                                                            Fees Unpaid
                                                            N/A
                                                            Withdrawn by Holder
                                                             
                                                            Filing Details
                                                            FLUTAMIDE
                                                            Flutamide
                                                            Issue/Submission Date
                                                            1993-09-24
                                                            2011-12-15
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                                                              Gestodene

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                                                              USDMF

                                                              Close USDMF

                                                              CEP/COS

                                                              Found CEP/COS

                                                              R1-CEP 2009-403 - Rev 01
                                                              Valid
                                                              Gestodene, Micronised
                                                              2020-01-31
                                                              Japanese DMF

                                                              Close JDMF

                                                              Written Confirmation

                                                              Close WC

                                                              Application Number
                                                              R1-CEP 2009-403 - Rev 01
                                                              Status
                                                              Valid
                                                               
                                                              Filing Details
                                                              Gestodene, Micronised
                                                              Issue/Submission Date
                                                              2020-01-31
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                                                                Gestodene

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                                                                USDMF

                                                                Close USDMF

                                                                CEP/COS

                                                                Found CEP/COS

                                                                R1-CEP 2011-026 - Rev 01
                                                                Valid
                                                                Gestodene, Crystallised
                                                                2020-01-31
                                                                Japanese DMF

                                                                Close JDMF

                                                                Written Confirmation

                                                                Close WC

                                                                Application Number
                                                                R1-CEP 2011-026 - Rev 01
                                                                Status
                                                                Valid
                                                                 
                                                                Filing Details
                                                                Gestodene, Crystallised
                                                                Issue/Submission Date
                                                                2020-01-31
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                                                                  Levonorgestrel

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                                                                  USDMF

                                                                  Found USDMF

                                                                  9136
                                                                  Active
                                                                  NORGESTREL USP
                                                                  1991-05-20
                                                                  CEP/COS

                                                                  Close CEP/COS

                                                                  Japanese DMF

                                                                  Close JDMF

                                                                  Written Confirmation

                                                                  Close WC

                                                                  Application Number
                                                                  9136
                                                                  Status
                                                                  Active
                                                                  Fees Unpaid
                                                                  N/A
                                                                   
                                                                  Filing Details
                                                                  NORGESTREL USP
                                                                  Issue/Submission Date
                                                                  1991-05-20
                                                                  ASK
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                                                                    Levonorgestrel

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                                                                    USDMF

                                                                    Found USDMF

                                                                    35419
                                                                    Active
                                                                    NORGESTREL USP
                                                                    2020-12-16
                                                                    CEP/COS

                                                                    Close CEP/COS

                                                                    Japanese DMF

                                                                    Close JDMF

                                                                    Written Confirmation

                                                                    Close WC

                                                                    Application Number
                                                                    35419
                                                                    Status
                                                                    Active
                                                                    Fees Unpaid
                                                                    N/A
                                                                     
                                                                    Filing Details
                                                                    NORGESTREL USP
                                                                    Issue/Submission Date
                                                                    2020-12-16
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                                                                      Norelgestromin

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                                                                      USDMF

                                                                      Found USDMF

                                                                      16404
                                                                      Active
                                                                      NORELGESTROMIN USP
                                                                      2003-02-03
                                                                      CEP/COS

                                                                      Close CEP/COS

                                                                      Japanese DMF

                                                                      Close JDMF

                                                                      Written Confirmation

                                                                      Close WC

                                                                      Application Number
                                                                      16404
                                                                      Status
                                                                      Active
                                                                      Fees Unpaid
                                                                      Reviewed
                                                                       
                                                                      Filing Details
                                                                      NORELGESTROMIN USP
                                                                      Issue/Submission Date
                                                                      2003-02-03
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                                                                        Norethisterone Acetate

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                                                                        USDMF

                                                                        Close USDMF

                                                                        CEP/COS

                                                                        Found CEP/COS

                                                                        R0-CEP 2021-402 - Rev 00
                                                                        Valid
                                                                        Norethisterone acetate
                                                                        2022-11-22
                                                                        Japanese DMF

                                                                        Close JDMF

                                                                        Written Confirmation

                                                                        Close WC

                                                                        Application Number
                                                                        R0-CEP 2021-402 - Rev 00
                                                                        Status
                                                                        Valid
                                                                         
                                                                        Filing Details
                                                                        Norethisterone acetate
                                                                        Issue/Submission Date
                                                                        2022-11-22
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                                                                          Norgestimate

                                                                          PDF Supplier PDF
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                                                                          USDMF

                                                                          Found USDMF

                                                                          19429
                                                                          Active
                                                                          NORGESTIMATE USP
                                                                          2006-05-15
                                                                          CEP/COS

                                                                          Close CEP/COS

                                                                          Japanese DMF

                                                                          Close JDMF

                                                                          Written Confirmation

                                                                          Close WC

                                                                          Application Number
                                                                          19429
                                                                          Status
                                                                          Active
                                                                          Fees Unpaid
                                                                          Reviewed
                                                                           
                                                                          Filing Details
                                                                          NORGESTIMATE USP
                                                                          Issue/Submission Date
                                                                          2006-05-15
                                                                          ASK
                                                                          US
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                                                                            Ondansetron Hydrochloride

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                                                                            USDMF

                                                                            Close USDMF

                                                                            CEP/COS

                                                                            Found CEP/COS

                                                                            R1-CEP 2003-053 - Rev 01
                                                                            Valid
                                                                            Ondansetron hydrochloride dihydrate
                                                                            2011-08-22
                                                                            Japanese DMF

                                                                            Close JDMF

                                                                            Written Confirmation

                                                                            Close WC

                                                                            Application Number
                                                                            R1-CEP 2003-053 - Rev 01
                                                                            Status
                                                                            Valid
                                                                             
                                                                            Filing Details
                                                                            Ondansetron hydrochloride dihydrate
                                                                            Issue/Submission Date
                                                                            2011-08-22
                                                                            ASK
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                                                                              Paroxetine Hydrochloride

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                                                                              USDMF

                                                                              Close USDMF

                                                                              CEP/COS

                                                                              Found CEP/COS

                                                                              R1-CEP 2003-250 - Rev 02
                                                                              Valid
                                                                              Paroxetine hydrochloride hemihydrat...
                                                                              2022-07-28
                                                                              Japanese DMF

                                                                              Close JDMF

                                                                              Written Confirmation

                                                                              Close WC

                                                                              Application Number
                                                                              R1-CEP 2003-250 - Rev 02
                                                                              Status
                                                                              Valid
                                                                               
                                                                              Filing Details
                                                                              Paroxetine hydrochloride hemihydrat...
                                                                              Issue/Submission Date
                                                                              2022-07-28
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                                                                                Teriparatide Acetate

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                                                                                USDMF

                                                                                Found USDMF

                                                                                29122
                                                                                Active
                                                                                TERIPARATIDE
                                                                                2015-04-01
                                                                                CEP/COS

                                                                                Close CEP/COS

                                                                                Japanese DMF

                                                                                Close JDMF

                                                                                Written Confirmation

                                                                                Close WC

                                                                                Application Number
                                                                                29122
                                                                                Status
                                                                                Active
                                                                                Fees Unpaid
                                                                                Reviewed
                                                                                 
                                                                                Filing Details
                                                                                TERIPARATIDE
                                                                                Issue/Submission Date
                                                                                2015-04-01
                                                                                ASK
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                                                                                  Ulipristal Acetate

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                                                                                  USDMF

                                                                                  Found USDMF

                                                                                  26861
                                                                                  Active
                                                                                  ULIPRISTAL ACETATE MICRONIZED
                                                                                  2013-02-04
                                                                                  CEP/COS

                                                                                  Close CEP/COS

                                                                                  Japanese DMF

                                                                                  Close JDMF

                                                                                  Written Confirmation

                                                                                  Close WC

                                                                                  Application Number
                                                                                  26861
                                                                                  Status
                                                                                  Active
                                                                                  Fees Unpaid
                                                                                  N/A
                                                                                   
                                                                                  Filing Details
                                                                                  ULIPRISTAL ACETATE MICRONIZED
                                                                                  Issue/Submission Date
                                                                                  2013-02-04
                                                                                  ASK
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                                                                                    Vinpocetine

                                                                                    PDF Supplier PDF
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                                                                                    USDMF

                                                                                    Close USDMF

                                                                                    CEP/COS

                                                                                    Found CEP/COS

                                                                                    R1-CEP 2011-059 - Rev 01
                                                                                    Valid
                                                                                    Vinpocetine
                                                                                    2020-05-18
                                                                                    Japanese DMF

                                                                                    Close JDMF

                                                                                    Written Confirmation

                                                                                    Close WC

                                                                                    Application Number
                                                                                    R1-CEP 2011-059 - Rev 01
                                                                                    Status
                                                                                    Valid
                                                                                     
                                                                                    Filing Details
                                                                                    Vinpocetine
                                                                                    Issue/Submission Date
                                                                                    2020-05-18
                                                                                    ASK
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                                                                                      Butoconazole Nitrate

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                                                                                      USDMF

                                                                                      Caution USDMF

                                                                                      15929
                                                                                      Inactive
                                                                                      BUTOCONAZOLE NITRATE
                                                                                      2002-04-08
                                                                                      CEP/COS

                                                                                      Close CEP/COS

                                                                                      Japanese DMF

                                                                                      Close JDMF

                                                                                      Written Confirmation

                                                                                      Close WC

                                                                                      Application Number
                                                                                      15929
                                                                                      Status
                                                                                      Inactive
                                                                                      Fees Unpaid
                                                                                      N/A
                                                                                       
                                                                                      Filing Details
                                                                                      BUTOCONAZOLE NITRATE
                                                                                      Issue/Submission Date
                                                                                      2002-04-08
                                                                                      ASK
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                                                                                        Cabergoline

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                                                                                        USDMF

                                                                                        Caution USDMF

                                                                                        18199
                                                                                        Inactive
                                                                                        CABERGOLINE
                                                                                        2005-03-21
                                                                                        CEP/COS

                                                                                        Close CEP/COS

                                                                                        Japanese DMF

                                                                                        Close JDMF

                                                                                        Written Confirmation

                                                                                        Close WC

                                                                                        Application Number
                                                                                        18199
                                                                                        Status
                                                                                        Inactive
                                                                                        Fees Unpaid
                                                                                        N/A
                                                                                         
                                                                                        Filing Details
                                                                                        CABERGOLINE
                                                                                        Issue/Submission Date
                                                                                        2005-03-21
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                                                                                          Finasteride

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                                                                                          USDMF

                                                                                          Caution USDMF

                                                                                          17575
                                                                                          Inactive
                                                                                          FINASTERIDE USP
                                                                                          2004-07-26
                                                                                          CEP/COS

                                                                                          Close CEP/COS

                                                                                          Japanese DMF

                                                                                          Close JDMF

                                                                                          Written Confirmation

                                                                                          Close WC

                                                                                          Application Number
                                                                                          17575
                                                                                          Status
                                                                                          Inactive
                                                                                          Fees Unpaid
                                                                                          N/A
                                                                                           
                                                                                          Filing Details
                                                                                          FINASTERIDE USP
                                                                                          Issue/Submission Date
                                                                                          2004-07-26
                                                                                          ASK
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                                                                                            Glutethimide

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                                                                                            USDMF

                                                                                            Caution USDMF

                                                                                            12616
                                                                                            Inactive
                                                                                            GLUTETHIMIDE
                                                                                            1997-06-09
                                                                                            CEP/COS

                                                                                            Close CEP/COS

                                                                                            Japanese DMF

                                                                                            Close JDMF

                                                                                            Written Confirmation

                                                                                            Close WC

                                                                                            Application Number
                                                                                            12616
                                                                                            Status
                                                                                            Inactive
                                                                                            Fees Unpaid
                                                                                            N/A
                                                                                             
                                                                                            Filing Details
                                                                                            GLUTETHIMIDE
                                                                                            Issue/Submission Date
                                                                                            1997-06-09
                                                                                            ASK
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                                                                                              Lamotrigine

                                                                                              PDF Supplier PDF
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                                                                                              USDMF

                                                                                              Caution USDMF

                                                                                              18353
                                                                                              Inactive
                                                                                              LAMOTRIGINE
                                                                                              2005-05-17
                                                                                              CEP/COS

                                                                                              Close CEP/COS

                                                                                              Japanese DMF

                                                                                              Close JDMF

                                                                                              Written Confirmation

                                                                                              Close WC

                                                                                              Application Number
                                                                                              18353
                                                                                              Status
                                                                                              Inactive
                                                                                              Fees Unpaid
                                                                                              N/A
                                                                                               
                                                                                              Filing Details
                                                                                              LAMOTRIGINE
                                                                                              Issue/Submission Date
                                                                                              2005-05-17
                                                                                              ASK
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                                                                                                Norelgestromin

                                                                                                PDF Supplier PDF
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                                                                                                USDMF

                                                                                                Caution USDMF

                                                                                                13025
                                                                                                Inactive
                                                                                                17-DEACETYL NORGESTIMATE
                                                                                                1998-06-17
                                                                                                CEP/COS

                                                                                                Close CEP/COS

                                                                                                Japanese DMF

                                                                                                Close JDMF

                                                                                                Written Confirmation

                                                                                                Close WC

                                                                                                Application Number
                                                                                                13025
                                                                                                Status
                                                                                                Inactive
                                                                                                Fees Unpaid
                                                                                                N/A
                                                                                                 
                                                                                                Filing Details
                                                                                                17-DEACETYL NORGESTIMATE
                                                                                                Issue/Submission Date
                                                                                                1998-06-17
                                                                                                ASK
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                                                                                                  Oxandrolone

                                                                                                  PDF Supplier PDF
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                                                                                                  USDMF

                                                                                                  Caution USDMF

                                                                                                  15427
                                                                                                  Inactive
                                                                                                  OXANDROLONE
                                                                                                  2001-05-17
                                                                                                  CEP/COS

                                                                                                  Close CEP/COS

                                                                                                  Japanese DMF

                                                                                                  Close JDMF

                                                                                                  Written Confirmation

                                                                                                  Close WC

                                                                                                  Application Number
                                                                                                  15427
                                                                                                  Status
                                                                                                  Inactive
                                                                                                  Fees Unpaid
                                                                                                  N/A
                                                                                                   
                                                                                                  Filing Details
                                                                                                  OXANDROLONE
                                                                                                  Issue/Submission Date
                                                                                                  2001-05-17
                                                                                                  ASK
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                                                                                                    Risperidone

                                                                                                    PDF Supplier PDF
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                                                                                                    USDMF

                                                                                                    Caution USDMF

                                                                                                    18446
                                                                                                    Inactive
                                                                                                    RISPERIDONE
                                                                                                    2005-06-23
                                                                                                    CEP/COS

                                                                                                    Close CEP/COS

                                                                                                    Japanese DMF

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                                                                                                    Written Confirmation

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                                                                                                    Application Number
                                                                                                    18446
                                                                                                    Status
                                                                                                    Inactive
                                                                                                    Fees Unpaid
                                                                                                    N/A
                                                                                                     
                                                                                                    Filing Details
                                                                                                    RISPERIDONE
                                                                                                    Issue/Submission Date
                                                                                                    2005-06-23
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                                                                                                      Ulipristal Acetate

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                                                                                                      USDMF

                                                                                                      Caution USDMF

                                                                                                      12920
                                                                                                      Inactive
                                                                                                      CDB-2914
                                                                                                      1998-04-07
                                                                                                      CEP/COS

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                                                                                                      Japanese DMF

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                                                                                                      Written Confirmation

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                                                                                                      Application Number
                                                                                                      12920
                                                                                                      Status
                                                                                                      Inactive
                                                                                                      Fees Unpaid
                                                                                                      N/A
                                                                                                       
                                                                                                      Filing Details
                                                                                                      CDB-2914
                                                                                                      Issue/Submission Date
                                                                                                      1998-04-07
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                                                                                                        VINCA ROSEA EXTRACT

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                                                                                                        USDMF

                                                                                                        Caution USDMF

                                                                                                        11991
                                                                                                        Inactive
                                                                                                        VINCA ROSEA EXTRACT
                                                                                                        1996-06-03
                                                                                                        CEP/COS

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                                                                                                        Japanese DMF

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                                                                                                        Written Confirmation

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                                                                                                        Application Number
                                                                                                        11991
                                                                                                        Status
                                                                                                        Inactive
                                                                                                        Fees Unpaid
                                                                                                        N/A
                                                                                                         
                                                                                                        Filing Details
                                                                                                        VINCA ROSEA EXTRACT
                                                                                                        Issue/Submission Date
                                                                                                        1996-06-03
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