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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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    H. Lundbeck AS
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    Ottiliavej 9 2500 Valby
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    +45 3630 1311
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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
    II
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    DIAZOXIDE

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    LUNDBECK PHARMACEUTIC...
    Active
    7031
    Complete
    2017-06-02
    2017-05-01
    1987-06-22
    II
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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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    GABOXADOL MONOHYDRATE

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    H LUNDBECK AS
    Active
    18417
    N/A
    2005-06-09
    II
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    IMIPRAMINE HYDROCHLORIDE

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    LUNDBECK PHARMACEUTIC...
    Inactive
    1913
    N/A
    1972-04-05
    II
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    IMIPRAMINE PAMOATE

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    LUNDBECK PHARMACEUTIC...
    Active
    22104
    N/A
    2008-10-15
    II
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    LU AA21004 HYDROBROMIDE

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    H LUNDBECK AS
    Active
    21224
    N/A
    2008-01-17
    II
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    LU AA24530 HYDROBROMIDE

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    H LUNDBECK AS
    Inactive
    21844
    N/A
    2008-09-29
    II
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    MELPERONE HYDROCHLORIDE

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    LUNDBECK PHARMACEUTIC...
    Inactive
    20837
    N/A
    2007-07-27
    II
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    METOCLOPRAMIDE HCL MONOHYDRATE

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    LUNDBECK PHARMACEUTIC...
    Active
    4877
    Complete
    2016-07-28
    2016-07-21
    1983-03-26
    II
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    NITOMAN(TETRABENAZINE) TABLETS

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    LIFEHEALTH LTD
    Inactive
    14323
    N/A
    1999-07-25
    II
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    SERTINDOLE BULK DRUG SUBSTANCE

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    H LUNDBECK AND CO AS
    Inactive
    9414
    N/A
    1991-11-20
    II
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    TRIMIPRAMINE MALEATE

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    LUNDBECK PHARMACEUTIC...
    Active
    5900
    Complete
    2014-05-23
    2013-02-21
    1985-04-22
    II
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    FACILITY IN NYKOBING SJ., DENMARK

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    H LUNDBECK AND CO AS
    Inactive
    9413
    N/A
    1991-11-20
    II
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    LU 28-179-C, DRUG SUBSTANCE

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    H LUNDBECK AND CO AS
    Inactive
    13052
    N/A
    1998-07-02
    II
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    LU 28-179-CAPSULES

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    H LUNDBECK AND CO AS
    Inactive
    13053
    N/A
    1998-07-02
    II
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    LU 3-010

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    H LUNDBECK AND CO AS
    Inactive
    1803
    N/A
    1971-09-27
    II
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    LU-25-109-M DRUG SUBSTANCE

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    H LUNDBECK AS
    Inactive
    12257
    N/A
    1996-12-09
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    H LUNDBECK AS
    Inactive
    12382
    N/A
    1997-02-24
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    H LUNDBECK AS
    Inactive
    12381
    N/A
    1997-02-24
    II
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    • FDA
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    MANUFACTURING SITE, FACILITIES, PER...

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    H LUNDBECK AS
    Inactive
    12383
    N/A
    1997-02-24
    II
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