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

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    01 BETAMETHASONE ACETATE (STERILE) USP (1)

    02 CEFADROXIL (1)

    03 CORTISONE ACETATE, USP (MICRONIZED) (1)

    04 CYCLOPHOSPHAMIDE LYOPHILIZED FOR INJ(5 DOSAGE FORMS)BEDFORD,OHIO FAC (1)

    05 DASATINIB MONOHYDRATE (1)

    06 ENALAPRILAT USP (1)

    07 ERLOTINIB HYDROCHLORIDE (1)

    08 FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMMAN JORDON (1)

    09 GLYCOPYRROLATE USP (1)

    10 GRANISETRON HYDROCHLORIDE USP (1)

    11 HIK-078 (1)

    12 HIK-079 (1)

    13 HYDROCORTISONE USP (1)

    14 MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN AMMAN, JORDAN (1)

    15 METHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED (1)

    16 METHYLPREDNISOLONE ACETATE USP (STERILE) (1)

    17 MILRINONE, USP (1)

    18 NICARDIPINE HYDROCHLORIDE (1)

    19 NILOTINIB MONOHYDROCHLORIDE ANHYDROUS (1)

    20 ONDANSETRON HYDROCHLORIDE, USP (1)

    21 OXANDROLONE USP (1)

    22 PEG-L-ASPARAGINASE (1)

    23 PREDNISONE ANHYDROUS USP (1)

    24 SOLRIAETOL HYDROCHLORIDE (1)

    25 SUNITINIB L-MALATE (1)

    26 UMECLIDINIUM BROMIDE (1)

    27 ZOLEDRONIC ACID USP (1)

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    01 AL HIKMA PHARMACEUTICALS (1)

    02 BEN VENUE LABORATORIES INC (3)

    03 HIKMA PHARMACEUTICALS (7)

    04 HIKMA PHARMACEUTICALS LLC (10)

    05 HIKMA PHARMACEUTICALS PLC (4)

    06 HIKMACHEM BPC (2)

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    01 Jordan (19)

    02 U.S.A (4)

    03 United Kingdom (4)

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    01 Active (20)

    02 Inactive (7)

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    01 Complete (5)

    02 Blank (22)

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    BETAMETHASONE ACETATE (STERILE) USP

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    HIKMA PHARMACEUTICALS...
    Active
    18126
    N/A
    2005-02-28
    II
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    CEFADROXIL

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    HIKMACHEM BPC
    Inactive
    13220
    N/A
    1998-04-30
    II
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    CORTISONE ACETATE, USP (MICRONIZED)

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    HIKMA PHARMACEUTICALS...
    Inactive
    16659
    N/A
    2003-06-19
    II
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    CYCLOPHOSPHAMIDE LYOPHILIZED FOR IN...

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    BEN VENUE LABORATORIE...
    Inactive
    5541
    N/A
    1984-09-27
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    DASATINIB MONOHYDRATE

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    HIKMA PHARMACEUTICALS...
    Active
    30165
    N/A
    2015-12-29
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    ENALAPRILAT USP

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    HIKMA PHARMACEUTICALS...
    Active
    19809
    N/A
    2006-09-28
    II
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    ERLOTINIB HYDROCHLORIDE

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    HIKMA PHARMACEUTICALS...
    Active
    29437
    N/A
    2015-05-28
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    GLYCOPYRROLATE USP

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    HIKMA PHARMACEUTICALS...
    Active
    18727
    N/A
    2005-08-31
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    GRANISETRON HYDROCHLORIDE USP

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    HIKMA PHARMACEUTICALS
    Active
    25298
    N/A
    2011-09-11
    II
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    HYDROCORTISONE USP

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    HIKMA PHARMACEUTICALS
    Active
    16089
    N/A
    2002-08-06
    II
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