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

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    01 BULK GRF (1-29) NH2 (SERMORELIN ACETATE DRUG SUBSTANCE) (1)

    02 CELL CULTURE AND PROTEIN PURIFICATION, IN RANDOLPH, MA (1)

    03 CHLORTHALIDONE USP (1)

    04 DIBENZOSUBERONE (1)

    05 DIOCTYL SODIUM SULFOSUCCINATE (45% SOLUTION) (1)

    06 EUSOLEX 6300 OIL SOLUBLE UV-B-FILTER (1)

    07 LH ENRICHED FRACTION (1)

    08 MURINE MONOCLONAL ANTI-FSH ANTIBODY 9/14 (1)

    09 N,N-DICYCLOHEXYLCARBODIIMIDE, PRODUCT #11650 (1)

    10 PRODUCT 502006, VITAMIN K PHYTONADIONE (1)

    11 PROFASI (hCG) HUMAN CHORIONIC gonadotropin) (1)

    12 SODIUM DIETHYLDITHIOCARBAMATE TRIHYDRATE-EXTRA PURE (1)

    13 SODIUM FLUORIDE (1)

    14 STERILE DILUENT (0.3% M-CRESOL) (1)

    15 STERILE WATER FOR INJECTION (1)

    16 STILAMIN (SOMATOSTIN) (1)

    17 TECHNETIUM TC-99m PYROPHOSPHATE NDA 17-913 (1)

    18 VIA CASILINA PLANT IN ROME, ITALY (1)

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    01 E MERCK (8)

    02 EMD SERONO INC (1)

    03 LABORATOIRES SERONO SA (5)

    04 MERCK KGAA (1)

    05 SERONO INC (1)

    06 SERONO LABORATORIES INC (2)

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    01 Germany (18)

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    01 Active (2)

    02 Inactive (16)

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    01 Blank (18)

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      BULK GRF (1-29) NH2 (SERMORELIN ACE...

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      LABORATOIRES SERONO S...
      Inactive
      10293
      N/A
      1993-06-11
      II
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        CHLORTHALIDONE USP

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        E MERCK
        Inactive
        5016
        N/A
        1983-04-20
        II
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          DIBENZOSUBERONE

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          E MERCK
          Inactive
          3460
          N/A
          1979-03-07
          II
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            DIOCTYL SODIUM SULFOSUCCINATE (45% ...

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            E MERCK
            Inactive
            3106
            N/A
            1978-01-06
            II
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              N,N-DICYCLOHEXYLCARBODIIMIDE, PRODU...

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              E MERCK
              Inactive
              3423
              N/A
              1979-01-19
              II
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                PRODUCT 502006, VITAMIN K PHYTONADI...

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                E MERCK
                Inactive
                4418
                N/A
                1982-01-11
                II
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                  PROFASI (hCG) HUMAN CHORIONIC gonad...

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                  LABORATOIRES SERONO S...
                  Inactive
                  4461
                  N/A
                  1982-02-25
                  II
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                    SODIUM DIETHYLDITHIOCARBAMATE TRIHY...

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                    E MERCK
                    Inactive
                    6944
                    N/A
                    1987-04-22
                    II
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                      SODIUM FLUORIDE

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                      MERCK KGAA
                      Active
                      9280
                      N/A
                      1991-08-07
                      II
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                        STERILE WATER FOR INJECTION

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                        LABORATOIRES SERONO S...
                        Inactive
                        10473
                        N/A
                        1993-09-14
                        II
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