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

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    01 ADATANSERIN HYDROCHLORIDE (CRUDE) (1)

    02 ALPHA METHYLDOPA (1)

    03 AMLODIPINE BESILATE (1)

    04 AMLODIPINE BESYLATE (1)

    05 ASTEMIZOLE (1)

    06 AZELASTINE HYDROCHLORIDE (1)

    07 AZT (ZIDOVUDINE) (1)

    08 CARBIDOPA (1)

    09 CELECOXIB-TRAMADOL, CO CRYSTAL (1)

    10 CITALOPRAM HYDROBROMIDE (1)

    11 CIZOLIRTINE CITRATE (1)

    12 DABIGATRAN ETEXILATE MESYLATE (1)

    13 DICLOFENAC POTASSIUM (1)

    14 DICLOFENAC SODIUM (1)

    15 DICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE (1)

    16 DULOXETINE HYDROCHLORIDE (1)

    17 ENALAPRIL MALEATE (1)

    18 ENALAPRILAT (1)

    19 ERLOTINIB HYDROCHLORIDE (1)

    20 ESZOPICLONE (1)

    21 FACILITY AND OPERATING PROCEDURES (1)

    22 FELODIPINE (1)

    23 IBRUTINIB (1)

    24 INDOMETHACIN FOR HUMAN USE (1)

    25 KETOCONAZOLE (1)

    26 LANSOPRAZOLE (1)

    27 LESOPITRON DIHYDROCHLORIDE (1)

    28 LEVETIRACETAM (1)

    29 LEVETIRACETAM INJECTABLE GRADE/NON-STERILE (1)

    30 LISINOPRIL (1)

    31 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. (1)

    32 MELOXICAM (1)

    33 MEMANTINE HYDROCHLORIDE (1)

    34 METOPROLOL FUMARATE (1)

    35 METOPROLOL SUCCINATE (1)

    36 METOPROLOL TATRATE (1)

    37 MOEXIPRIL HYDROCHLORIDE (1)

    38 NABUMETONE (1)

    39 NEFAZODONE HYDRCHLORIDE (1)

    40 OMEPRAZOLE (2)

    41 PANTOPRAZOLE SODIUM (1)

    42 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

    43 PIROXICAM (1)

    44 QUINAPRIL HCL (1)

    45 RAMIPRIL (1)

    46 RILUZOLE (1)

    47 VPA-985 (1)

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    02 ESTEVE QUIMICA SA (46)

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    02 Inactive (39)

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    ADATANSERIN HYDROCHLORIDE (CRUDE)

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    ESTEVE QUIMICA SA
    Inactive
    15823
    N/A
    2002-01-24
    II
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    ALPHA METHYLDOPA

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    ESTEVE QUIMICA SA
    Inactive
    5966
    N/A
    1985-08-08
    II
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    AMLODIPINE BESILATE

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    ESTEVE QUIMICA SA
    Inactive
    15127
    N/A
    2000-11-02
    II
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    AMLODIPINE BESYLATE

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    ESTEVE QUIMICA SA
    Inactive
    22342
    N/A
    2008-12-17
    II
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    ASTEMIZOLE

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    ESTEVE QUIMICA SA
    Inactive
    11584
    N/A
    1995-07-13
    II
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    AZELASTINE HYDROCHLORIDE

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    ESTEVE QUIMICA SA
    Active
    22427
    Complete
    2013-11-20
    2013-11-14
    2009-01-20
    II
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    AZT (ZIDOVUDINE)

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    ESTEVE QUIMICA SA
    Inactive
    10866
    N/A
    1994-04-07
    II
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    CARBIDOPA

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    ESTEVE QUIMICA SA
    Inactive
    9061
    N/A
    1991-04-15
    II
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    CELECOXIB-TRAMADOL, CO CRYSTAL

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    ESTEVE QUIMICA SA
    Active
    33396
    N/A
    2019-02-04
    II
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    CITALOPRAM HYDROBROMIDE

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    ESTEVE QUIMICA SA
    Inactive
    17511
    N/A
    2004-07-01
    II
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