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

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    01 ALPIDEM (1)

    02 DL-LYSINE ACETYLSALICYLATE (1)

    03 ELIPRODIL HYDROCHLORIDE (1)

    04 FACILITY AT MOURENX, FRANCE (1)

    05 KETOISOLEUCINE L-ORNITHINE SALT (1)

    06 KETOLEUCINE L-HISTIDINE SALT (1)

    07 KETOLEUCINE L-LYSINE SALT (1)

    08 L-LYSINE ALPHA KETO BETA METHYLVALERATE - MONTARGIS CEDEX,FR (1)

    09 L-LYSINE AQUEOUS SOLUTION (1)

    10 L-ORNITHINE ALPHA KETO ISOCAPROATE (1)

    11 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AMILLY, FRANCE. (1)

    12 PLASMA HIV-RNA IN CLINICAL TRIALS IN BETHESDA, MARYLAND (1)

    13 PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE (1)

    14 THIAZEPIN (1)

    15 UREA-CALCIUM ACETYLSALICYLATE (1)

    16 ZOLPIDEM TARTRATE (1)

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    01 SYNTHELABO BP (4)

    02 SYNTHELABO PHARMACIE (10)

    03 SYNTHELABO RECHERCHE (2)

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    01 France (16)

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    01 Blank (16)

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      ALPIDEM

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      SYNTHELABO RECHERCHE
      Inactive
      9496
      N/A
      1992-01-10
      II
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        DL-LYSINE ACETYLSALICYLATE

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        SYNTHELABO BP
        Inactive
        8468
        N/A
        1990-03-12
        II
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          ELIPRODIL HYDROCHLORIDE

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          SYNTHELABO RECHERCHE
          Inactive
          10763
          N/A
          1994-02-28
          II
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            KETOISOLEUCINE L-ORNITHINE SALT

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            SYNTHELABO PHARMACIE
            Inactive
            5924
            N/A
            1985-07-05
            II
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              KETOLEUCINE L-HISTIDINE SALT

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              SYNTHELABO PHARMACIE
              Inactive
              5911
              N/A
              1985-07-05
              II
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                KETOLEUCINE L-LYSINE SALT

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                SYNTHELABO PHARMACIE
                Inactive
                5920
                N/A
                1985-07-05
                II
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                  L-LYSINE AQUEOUS SOLUTION

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                  SYNTHELABO PHARMACIE
                  Inactive
                  11301
                  N/A
                  1994-12-07
                  II
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                    L-ORNITHINE ALPHA KETO ISOCAPROATE

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                    SYNTHELABO BP
                    Inactive
                    8467
                    N/A
                    1990-03-12
                    II
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                      PRECLINICAL ANIMAL STUDIES FOR TRIP...

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                      SYNTHELABO PHARMACIE
                      Inactive
                      9816
                      N/A
                      1992-08-14
                      II
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                        THIAZEPIN

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                        SYNTHELABO PHARMACIE
                        Inactive
                        9544
                        N/A
                        1992-02-18
                        II
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