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

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    01 ACCUTANE (ISOTRETINOIN) (1)

    02 ALBUTEROL 8 MG, LOT E-14274 (1)

    03 AVC (SULFANILAMIDE) SUPPOSITORIES (1)

    04 CAPSULES VIT. A, 50,000 UNITS (15.0MG) AND 100,000 UNITS (30.0MG) (1)

    05 CAPSULES VITAMIN D, 50,000 UNITS (1.25MG) (1)

    06 CGS-9896 (1)

    07 DIGOXIN CAPS (1)

    08 DIOCTYL SODIUM SULFOSUCCINATE 100mg & GASANTHRANOL 30mg. CAPSULES. (1)

    09 ENPROSTIL CAPSULES (1)

    10 ETOPOSIDE 50MG SOFT-GELATIN CAPSULE (1)

    11 FACILITIES AND GENERAL OPERATING PROCEDURES (1)

    12 FACILITIES AND PERSONNEL IN SWINDON, WILTSHIRE, ENGLAND (1)

    13 FERROUS CITRATE (1)

    14 FERROUS CITRATE, MANUF SPECS & CLINICAL DATA (1)

    15 HARDSHELL GELATIN CAPS (1)

    16 HECTOROL, 1.0 MICROG SOFT GELATIN CAPSULES (1)

    17 HYDERGINE(ERGOLOID MESYLATES) 1MG SOFTGELS (1)

    18 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEIHEM, FRANCE (1)

    19 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BEINHEIM, FRANCE. (1)

    20 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. (1)

    21 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ST. PETERSBURG, FLORIDA. (1)

    22 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

    23 MAXEPA OIL (1)

    24 MCN-5691 (1)

    25 NIFEDIPINE SOFTGELS 10 MG (2)

    26 NIFEDIPINE SOFTGELS 10 MG, TO SUPPORT CHELSEA LABS. ANDA (1)

    27 NIFEDIPINE SOFTGELS 20 MG (1)

    28 NIFEDIPINE SOFTGELS 20 MG, KALIPHARMA, INC. (1)

    29 NIFEDIPINE SOFTGELS 20 MG, TO SUPPORT CHELSEA LABS. ANDA (1)

    30 OXYPHENBUTAZONE CAPSULE 100MG (1)

    31 PHENYLBUTAZONE CAPSULES 100MG (1)

    32 PRODUCTION FACILITIES AT MONROE, NORTH CAROLINA (1)

    33 PRODUCTION FACILITY IN DETROIT MICHIGAN (1)

    34 TEGRETOL S.R. CAPSULES (1)

    35 TIPRANAVIR CAPSULES 250 MG (IMPRINT) (1)

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    01 RP SCHERER CANADA INC (1)

    02 RP SCHERER CORP (17)

    03 RP SCHERER GMBH AND CO KG (1)

    04 RP SCHERER LTD (2)

    05 RP SCHERER NORTH AMERICA (2)

    06 RP SCHERER NORTH AMERICA DIV RP SCHERER CORP (13)

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    01 Germany (36)

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    01 Inactive (36)

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    01 Blank (36)

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      ACCUTANE (ISOTRETINOIN)

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      RP SCHERER NORTH AMER...
      Inactive
      14493
      N/A
      1999-10-14
      II
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        ALBUTEROL 8 MG, LOT E-14274

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        RP SCHERER NORTH AMER...
        Inactive
        7360
        N/A
        1988-02-25
        II
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          AVC (SULFANILAMIDE) SUPPOSITORIES

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          RP SCHERER NORTH AMER...
          Inactive
          15530
          N/A
          2001-07-17
          II
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            CAPSULES VITAMIN D, 50,000 UNITS (1...

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            RP SCHERER CORP
            Inactive
            1792
            N/A
            1971-09-15
            II
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              DIGOXIN CAPS

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              RP SCHERER CORP
              Inactive
              2253
              N/A
              1974-03-28
              II
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                DIOCTYL SODIUM SULFOSUCCINATE 100mg...

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                RP SCHERER CORP
                Inactive
                1729
                N/A
                1971-06-01
                II
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                  ENPROSTIL CAPSULES

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                  RP SCHERER NORTH AMER...
                  Inactive
                  5737
                  N/A
                  1985-02-12
                  II
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                    ETOPOSIDE 50MG SOFT-GELATIN CAPSULE

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                    RP SCHERER CANADA INC
                    Inactive
                    13986
                    N/A
                    1999-02-17
                    II
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                      FERROUS CITRATE

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                      RP SCHERER CORP
                      Inactive
                      389
                      N/A
                      1960-07-15
                      II
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                        FERROUS CITRATE, MANUF SPECS & CLIN...

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                        RP SCHERER CORP
                        Inactive
                        428
                        N/A
                        1961-04-11
                        II
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