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

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    01 Alendronate Sodium (1)

    02 Allylestrenol (1)

    03 Amlodipine Besylate (2)

    04 Azelastine Hydrochloride (1)

    05 Bicalutamide (1)

    06 Bisaramil (1)

    07 Bromocriptine Mesylate (1)

    08 Butoconazole Nitrate (1)

    09 CAS 50-28-2 (1)

    10 Cabergoline (1)

    11 Cariprazine Hydrochloride (1)

    12 Cimetidine (2)

    13 Cimetidine Hydrochloride (1)

    14 Desogestrel (1)

    15 Diazepam (1)

    16 Dienogest (1)

    17 Disopyramide (2)

    18 Drospirenone (4)

    19 Elymoclavine (1)

    20 Enalapril Maleate (1)

    21 Estetrol (1)

    22 Estradiol (1)

    23 Estradiol Valerate (1)

    24 Ethinyl Estradiol (3)

    25 Ethionamide (1)

    26 Ethynodiol Diacetate (1)

    27 Etonogestrel (1)

    28 Famotidine (1)

    29 Finasteride (1)

    30 Fluconazole (1)

    31 Flumecinol (1)

    32 Fluoxetine Hydrochloride (1)

    33 Flutamide (1)

    34 Gestodene (2)

    35 Glutethimide (1)

    36 Ketamine Hydrochloride (1)

    37 Lamotrigine (1)

    38 Levonorgestrel (3)

    39 Lisinopril (1)

    40 Mestranol (1)

    41 Nandrolone Decanoate (1)

    42 Norelgestromin (2)

    43 Norethisterone (2)

    44 Norethisterone Acetate (1)

    45 Norgestimate (2)

    46 Ondansetron Hydrochloride (1)

    47 Oxandrolone (1)

    48 Paroxetine Hydrochloride (1)

    49 Pipecuronium (1)

    50 Rgh 4417 (1)

    51 Risperidone (1)

    52 Spironolactone (1)

    53 Sulfinpyrazone (1)

    54 Tamsulosin (1)

    55 Telapristone (1)

    56 Terbinafine Hydrochloride (1)

    57 Teriparatide Acetate (1)

    58 Tolperisone (1)

    59 Ulipristal Acetate (2)

    60 Vinblastine Sulfate (2)

    61 Vincristine Sulfate (1)

    62 Vinpocetine (1)

    63 Blank (2)

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    01 Active (18)

    02 Inactive (47)

    03 Blank (15)

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    01 Expired (2)

    02 Valid (25)

    03 Withdrawn by Holder (5)

    04 Blank (48)

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    01 218MF10213 (1)

    02 218MF10443 (1)

    03 219MF10198 (1)

    04 220MF10116 (1)

    05 220MF10117 (1)

    06 305MF10111 (1)

    07 305MF10112 (1)

    08 Blank (73)

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    01 Blank (80)

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      Drospirenone

      PDF Supplier PDF
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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

              PDF Supplier PDF
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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

                PDF Supplier PDF
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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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