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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Synthon Chemicals Gmbh & Co. Kg to the U.S. FDA. Original Data : FDA Website

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    SYNTHON Chemicals GmbH & Co. KG

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    01 AMLODIPINE BESYLATE MONOHYDRATE (1)

    02 ANASTROLZOLE (1)

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    05 LEVOCETIRIZINE DIHYDROCHLORIDE (1)

    06 SIMVASTATIN (1)

    07 TAMSULOSIN HYDROCHLORIDE (1)

    08 ZOLPIDEM TARTRATE (1)

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      AMLODIPINE BESYLATE MONOHYDRATE

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      SYNTHON BV
      Inactive
      18872
      N/A
      2005-10-11
      II
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        ANASTROLZOLE

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        SYNTHON BV
        Inactive
        19211
        N/A
        2006-02-27
        II
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          ARIPIPRAZOLE

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          SYNTHON BV
          Inactive
          19682
          N/A
          2006-08-11
          II
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            GEFITINIB

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            SYNTHON BV
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            29797
            Complete
            2016-06-27
            2015-11-19
            2015-11-17
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              LEVOCETIRIZINE DIHYDROCHLORIDE

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              SYNTHON BV
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              24561
              N/A
              2011-01-19
              II
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                SIMVASTATIN

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                SYNTHON BV
                Inactive
                18384
                N/A
                2005-05-27
                II
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                  TAMSULOSIN HYDROCHLORIDE

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                  SYNTHON BV
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                  20082
                  N/A
                  2006-12-21
                  II
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                    ZOLPIDEM TARTRATE

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                    SYNTHON BV
                    Inactive
                    22668
                    N/A
                    2009-03-27
                    II
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