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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Gedeon Richter to the U.S. FDA. Original Data : FDA Website

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    01 17-DEACETYL NORGESTIMATE (1)

    02 AMLODIPINE BESYLATE (1)

    03 AZELASTINE HCL USP (1)

    04 BICALUTAMIDE (MICRONIZED) (1)

    05 BROMOCRIPTINE MESYLATE USP (1)

    06 BUTOCONAZOLE NITRATE (1)

    07 CABERGOLINE (1)

    08 CARIPRAZINE HYDROCHLORIDE (1)

    09 CDB-2914 (1)

    10 CDB-4124 (1)

    11 CIMETIDINE (1)

    12 CIMETIDINE HYDROCHLORIDE (1)

    13 DESOGESTREL (1)

    14 DIAZEPAM USP (1)

    15 DIENOGEST (1)

    16 DIHYDROLYSERGOL (1)

    17 DISOPYRAMIDE PHOSPHATE (1)

    18 DISOPYRAMIDE PHOSPHATE CAPSULES (1)

    19 DROSPIRENONE USP (1)

    20 ENALAPRIL MALEATE (1)

    21 ESTETROL MONOHYDRATE (1)

    22 ESTRADIOL USP (1)

    23 ESTRADIOL VALERATE (1)

    24 ETHINYL ESTRADIOL USP (1)

    25 ETHIONAMIDE (1)

    26 ETHYNODIOL DIACETATE (1)

    27 ETONOGESTREL (1)

    28 FAMOTIDINE, USP (1)

    29 FINASTERIDE USP (1)

    30 FLUCONAZOLE (1)

    31 FLUMECINOL (1)

    32 FLUTAMIDE (1)

    33 FOR CHEMICAL WORKS OF GEDEON RICHTER, LTD -BUDAPEST (1)

    34 GLUTETHIMIDE (1)

    35 KETAMINE HCL (1)

    36 LAMOTRIGINE (1)

    37 LEVONORGESTREL, USP (1)

    38 LISINOPRIL (1)

    39 MESTRANOL (1)

    40 NANDROLONE DECANOATE (1)

    41 NORELGESTROMIN USP (1)

    42 NORETHINDRONE 0.5 MG. AND ETHINYL ESTRADIOL 0.035 (1)

    43 NORETHINDRONE 0.75 MG. AND ETHINYL ESTRADIOL 0.035 MG. TABLET (1)

    44 NORETHINDRONE 1 MG. AND ETHINYL ESTRADIOL 0.035 MG. USP TABS. (1)

    45 NORETHINDRONE 1 MG. AND MESTRANOL 0.05 MG. TABLETS IN BULK (1)

    46 NORETHISTERONE (1)

    47 NORGESTIMATE (1)

    48 NORGESTIMATE USP (1)

    49 NORGESTREL USP (2)

    50 OXANDROLONE (1)

    51 PIPECURONIUM BROMIDE (1)

    52 RGH-2957 (1)

    53 RGH-4417 (1)

    54 RISPERIDONE (1)

    55 SPIRONOLACTONE USP (1)

    56 SULFINPYRAZONE (1)

    57 TAMSULOSIN HYDROCHLORIDE (1)

    58 TERBINAFINE HYDROCHLORIDE USP (1)

    59 TERIPARATIDE (1)

    60 TOLPERISONE HCl (1)

    61 ULIPRISTAL ACETATE MICRONIZED (1)

    62 VINBLASTIN S04 (1)

    63 VINCA ROSEA EXTRACT (1)

    64 VINCRISTINE SULFATE (1)

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    01 CHEMICAL WORKS OF GEDEON RICHTER PLC DBA GEDEON RICHTER PLC (1)

    02 GEDEON RICHTER LTD (36)

    03 GEDEON RICHTER PLC (26)

    04 GEDEON RICHTER USA INC (1)

    05 RICHTER-HELM BIOTEC GMBH AND CO KG (1)

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    01 Germany (1)

    02 Hungary (64)

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    01 Active (18)

    02 Inactive (47)

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    01 Complete (6)

    02 Blank (59)

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      17-DEACETYL NORGESTIMATE

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      GEDEON RICHTER PLC
      Inactive
      13025
      N/A
      1998-06-17
      II
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        AMLODIPINE BESYLATE

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        GEDEON RICHTER LTD
        Inactive
        17584
        N/A
        2004-08-02
        II
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          AZELASTINE HCL USP

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          GEDEON RICHTER PLC
          Active
          15361
          Complete
          2015-02-25
          2015-02-18
          2001-03-29
          II
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            BICALUTAMIDE (MICRONIZED)

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            GEDEON RICHTER LTD
            Inactive
            18776
            N/A
            2005-09-15
            II
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              BROMOCRIPTINE MESYLATE USP

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              GEDEON RICHTER LTD
              Inactive
              6737
              N/A
              1986-12-16
              II
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                BUTOCONAZOLE NITRATE

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                GEDEON RICHTER PLC
                Inactive
                15929
                N/A
                2002-04-08
                II
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                  CABERGOLINE

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                  GEDEON RICHTER PLC
                  Inactive
                  18199
                  N/A
                  2005-03-21
                  II
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                    CARIPRAZINE HYDROCHLORIDE

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                    GEDEON RICHTER PLC
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                    26321
                    N/A
                    2012-07-26
                    II
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                      CDB-2914

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                      GEDEON RICHTER LTD
                      Inactive
                      12920
                      N/A
                      1998-04-07
                      II
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                        CDB-4124

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                        GEDEON RICHTER PLC
                        Inactive
                        21148
                        N/A
                        2007-12-18
                        II
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