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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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    APIs // Active Pharmaceutical Ingredients

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    Gedeon Richter
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    Hungary
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    1103, Gyömrői road 19-21,Budapest
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    36 143 140 00
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    enquiries@pharmacompass.com
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    http://www.richter.hu/hu-HU/Pages/default.aspx
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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
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        17584
        N/A
        2004-08-02
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          AZELASTINE HCL USP

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

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

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

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                GEDEON RICHTER PLC
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                15929
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                2002-04-08
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                  CABERGOLINE

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                  GEDEON RICHTER PLC
                  Inactive
                  18199
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                  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
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                      12920
                      N/A
                      1998-04-07
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                        CDB-4124

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                        GEDEON RICHTER PLC
                        Inactive
                        21148
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                        2007-12-18
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                          CIMETIDINE

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                          GEDEON RICHTER LTD
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                          9637
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                          1992-04-09
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                            CIMETIDINE HYDROCHLORIDE

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                            GEDEON RICHTER LTD
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                            9769
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                            1992-07-08
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                              DESOGESTREL

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                              GEDEON RICHTER PLC
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                              12368
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                              1997-02-18
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                                DIAZEPAM USP

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                                GEDEON RICHTER LTD
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                                6071
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                                1985-10-07
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                                  DIENOGEST

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                                  GEDEON RICHTER PLC
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                                  24479
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                                  2010-12-21
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                                    DIHYDROLYSERGOL

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                                    GEDEON RICHTER LTD
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                                    8802
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                                    1990-10-24
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                                      DISOPYRAMIDE PHOSPHATE

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                                      GEDEON RICHTER LTD
                                      Inactive
                                      5732
                                      N/A
                                      1985-02-28
                                      II
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                                        DISOPYRAMIDE PHOSPHATE CAPSULES

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                                        GEDEON RICHTER LTD
                                        Inactive
                                        6204
                                        N/A
                                        1986-01-10
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                                          DROSPIRENONE USP

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                                          GEDEON RICHTER PLC
                                          Active
                                          17866
                                          N/A
                                          2004-12-03
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                                            ENALAPRIL MALEATE

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                                            GEDEON RICHTER LTD
                                            Inactive
                                            12939
                                            N/A
                                            1998-04-08
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                                              ESTETROL MONOHYDRATE

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                                              GEDEON RICHTER PLC
                                              Active
                                              37136
                                              N/A
                                              2022-06-10
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                                                ESTRADIOL USP

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                                                GEDEON RICHTER PLC
                                                Active
                                                4066
                                                Complete
                                                2016-05-24
                                                2016-04-26
                                                1981-01-21
                                                II
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                                                  ESTRADIOL VALERATE

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                                                  GEDEON RICHTER PLC
                                                  Inactive
                                                  24553
                                                  N/A
                                                  2011-01-18
                                                  II
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                                                    ETHINYL ESTRADIOL USP

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                                                    CHEMICAL WORKS OF GED...
                                                    Active
                                                    5740
                                                    N/A
                                                    1985-02-27
                                                    II
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                                                      ETHIONAMIDE

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                                                      GEDEON RICHTER LTD
                                                      Inactive
                                                      5604
                                                      N/A
                                                      1984-11-07
                                                      II
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                                                        ETHYNODIOL DIACETATE

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                                                        GEDEON RICHTER LTD
                                                        Inactive
                                                        1895
                                                        N/A
                                                        1986-07-11
                                                        II
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                                                          ETONOGESTREL

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                                                          GEDEON RICHTER PLC
                                                          Active
                                                          11997
                                                          Complete
                                                          2014-10-22
                                                          2014-03-26
                                                          1996-06-10
                                                          II
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                                                            FAMOTIDINE, USP

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                                                            GEDEON RICHTER PLC
                                                            Active
                                                            11537
                                                            N/A
                                                            1995-06-05
                                                            II
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                                                              FINASTERIDE USP

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                                                              GEDEON RICHTER PLC
                                                              Inactive
                                                              17575
                                                              N/A
                                                              2004-07-26
                                                              II
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                                                                FLUCONAZOLE

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                                                                GEDEON RICHTER LTD
                                                                Inactive
                                                                15883
                                                                N/A
                                                                2002-03-04
                                                                II
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                                                                  FLUMECINOL

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                                                                  GEDEON RICHTER LTD
                                                                  Inactive
                                                                  5449
                                                                  N/A
                                                                  1984-06-25
                                                                  II
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                                                                    FLUTAMIDE

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                                                                    GEDEON RICHTER USA IN...
                                                                    Inactive
                                                                    10497
                                                                    N/A
                                                                    1993-09-24
                                                                    II
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                                                                      GLUTETHIMIDE

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                                                                      GEDEON RICHTER LTD
                                                                      Inactive
                                                                      12616
                                                                      N/A
                                                                      1997-06-09
                                                                      II
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                                                                        KETAMINE HCL

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                                                                        GEDEON RICHTER LTD
                                                                        Inactive
                                                                        5462
                                                                        N/A
                                                                        1984-07-17
                                                                        II
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                                                                          LAMOTRIGINE

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                                                                          GEDEON RICHTER LTD
                                                                          Inactive
                                                                          18353
                                                                          N/A
                                                                          2005-05-17
                                                                          II
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                                                                            LEVONORGESTREL, USP

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                                                                            GEDEON RICHTER PLC
                                                                            Active
                                                                            8806
                                                                            N/A
                                                                            1990-10-30
                                                                            II
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                                                                              LISINOPRIL

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                                                                              GEDEON RICHTER LTD
                                                                              Inactive
                                                                              12912
                                                                              N/A
                                                                              1998-01-26
                                                                              II
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                                                                                MESTRANOL

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                                                                                GEDEON RICHTER LTD
                                                                                Inactive
                                                                                5744
                                                                                N/A
                                                                                1985-02-28
                                                                                II
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                                                                                  NANDROLONE DECANOATE

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                                                                                  GEDEON RICHTER LTD
                                                                                  Inactive
                                                                                  3503
                                                                                  N/A
                                                                                  1979-04-05
                                                                                  II
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                                                                                    NORELGESTROMIN USP

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                                                                                    GEDEON RICHTER PLC
                                                                                    Active
                                                                                    16404
                                                                                    Complete
                                                                                    2019-05-12
                                                                                    2019-04-29
                                                                                    2003-02-03
                                                                                    II
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                                                                                      NORETHINDRONE 0.5 MG. AND ETHINYL E...

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                                                                                      GEDEON RICHTER LTD
                                                                                      Inactive
                                                                                      7332
                                                                                      N/A
                                                                                      1988-02-16
                                                                                      II
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                                                                                        NORETHINDRONE 0.75 MG. AND ETHINYL ...

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                                                                                        GEDEON RICHTER LTD
                                                                                        Inactive
                                                                                        7466
                                                                                        N/A
                                                                                        1988-05-11
                                                                                        II
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                                                                                          NORETHINDRONE 1 MG. AND ETHINYL EST...

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                                                                                          GEDEON RICHTER LTD
                                                                                          Inactive
                                                                                          6660
                                                                                          N/A
                                                                                          1986-10-02
                                                                                          II
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                                                                                            NORETHINDRONE 1 MG. AND MESTRANOL 0...

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                                                                                            GEDEON RICHTER LTD
                                                                                            Inactive
                                                                                            6639
                                                                                            N/A
                                                                                            1986-10-02
                                                                                            II
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                                                                                              NORETHISTERONE

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                                                                                              GEDEON RICHTER LTD
                                                                                              Inactive
                                                                                              3353
                                                                                              N/A
                                                                                              1978-11-10
                                                                                              II
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                                                                                                NORGESTIMATE

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                                                                                                GEDEON RICHTER PLC
                                                                                                Inactive
                                                                                                5708
                                                                                                N/A
                                                                                                1985-01-21
                                                                                                II
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                                                                                                  NORGESTIMATE USP

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                                                                                                  GEDEON RICHTER PLC
                                                                                                  Active
                                                                                                  19429
                                                                                                  Complete
                                                                                                  2017-05-02
                                                                                                  2017-04-18
                                                                                                  2006-05-15
                                                                                                  II
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                                                                                                    NORGESTREL USP

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                                                                                                    GEDEON RICHTER PLC
                                                                                                    Active
                                                                                                    9136
                                                                                                    N/A
                                                                                                    1991-05-20
                                                                                                    II
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                                                                                                      NORGESTREL USP

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                                                                                                      GEDEON RICHTER PLC
                                                                                                      Active
                                                                                                      35419
                                                                                                      N/A
                                                                                                      2020-12-16
                                                                                                      II
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                                                                                                        OXANDROLONE

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                                                                                                        GEDEON RICHTER PLC
                                                                                                        Inactive
                                                                                                        15427
                                                                                                        N/A
                                                                                                        2001-05-17
                                                                                                        II
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