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

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    01 ALFUZOSIN HYDROCHLORIDE (1)

    02 ARGATROBAN (1)

    03 CALCIUM - AMPHOMYCIN (1)

    04 CITALOPRAM HYDROBROMIDE (1)

    05 CLOMIPRAMINE HYDROCHLORIDE (1)

    06 DAPSONE (1)

    07 DESIPRAMINE HYDROCHLORIDE (1)

    08 DIAZOXIDE (1)

    09 ESCITALOPRAM OXALATE (1)

    10 ETHOTOIN (1)

    11 FACILITY IN NYKOBING SJ., DENMARK (1)

    12 GABOXADOL MONOHYDRATE (1)

    13 IMIPRAMINE HYDROCHLORIDE (1)

    14 IMIPRAMINE PAMOATE (1)

    15 LU 28-179-C, DRUG SUBSTANCE (1)

    16 LU 28-179-CAPSULES (1)

    17 LU 3-010 (1)

    18 LU AA21004 HYDROBROMIDE (1)

    19 LU AA24530 HYDROBROMIDE (1)

    20 LU-25-109-M DRUG SUBSTANCE (1)

    21 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SEAL SANDS, UNITED KINGDOM (1)

    22 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN VALBY, DENMARK (1)

    23 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LAMSAS, DENMARK (1)

    24 MELPERONE HYDROCHLORIDE (1)

    25 METOCLOPRAMIDE HCL MONOHYDRATE (1)

    26 NITOMAN(TETRABENAZINE) TABLETS (1)

    27 SERTINDOLE BULK DRUG SUBSTANCE (1)

    28 TRIMIPRAMINE MALEATE (1)

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    01 H LUNDBECK AND CO AS (6)

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    03 LIFEHEALTH LTD (1)

    04 LUNDBECK PHARMACEUTICALS ITALY SPA (12)

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    ALFUZOSIN HYDROCHLORIDE

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    LUNDBECK PHARMACEUTIC...
    Inactive
    20540
    N/A
    2007-05-15
    II
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    ARGATROBAN

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    LUNDBECK PHARMACEUTIC...
    Active
    21304
    Complete
    2013-10-05
    2013-09-26
    2008-01-30
    II
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    CALCIUM - AMPHOMYCIN

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    H LUNDBECK AND CO AS
    Inactive
    433
    N/A
    1961-05-12
    II
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    CITALOPRAM HYDROBROMIDE

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    H LUNDBECK AS
    Active
    12384
    N/A
    1997-02-24
    II
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    CLOMIPRAMINE HYDROCHLORIDE

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    LUNDBECK PHARMACEUTIC...
    Active
    8864
    Complete
    2015-02-25
    2015-01-26
    1990-11-19
    II
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    DAPSONE

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    LUNDBECK PHARMACEUTIC...
    Active
    15065
    N/A
    2000-09-29
    II
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    DESIPRAMINE HYDROCHLORIDE

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    LUNDBECK PHARMACEUTIC...
    Active
    3374
    Complete
    2015-01-26
    2014-03-26
    1978-10-04
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    DIAZOXIDE

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    LUNDBECK PHARMACEUTIC...
    Active
    7031
    Complete
    2017-06-02
    2017-05-01
    1987-06-22
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    ESCITALOPRAM OXALATE

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    H LUNDBECK AS
    Active
    14103
    N/A
    1999-04-29
    II
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    ETHOTOIN

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    LUNDBECK PHARMACEUTIC...
    Inactive
    25673
    N/A
    2012-04-10
    II
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