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

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    01 ADAPALENE (1)

    02 ANAMORELIN HYDROCHLORIDE (API) (1)

    03 ANAMORELIN HYDROCHLORIDE, 100 MG TABLETS (1)

    04 CHLORZOXAZONE DRUG SUBSTANCE (1)

    05 DANTROLENE SODIUM DRUG SUBSTANCE (1)

    06 DMSAM (1)

    07 FOSNETUPITANT CHLORIDE (1)

    08 GUANABENZ ACETATE (1)

    09 ISOTRETINOIN (1)

    10 MELATONIN (1)

    11 MODAFINIL (1)

    12 NETUPITANT (1)

    13 PALONOSETRON HYDROCHLORIDE USP (1)

    14 PYRIDOSTIGMINE BROMIDE (1)

    15 SODIUM BENZOATE (1)

    16 TRAMADOL HYDROCHLORIDE (1)

    17 TRIFAROTENE (1)

    18 TROSPIUM CHLORIDE (1)

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    01 HAS HEALTHCARE ADVANCED SYNTHESIS SA (10)

    02 HELSINN ADVANCED SYNTHESIS SA (2)

    03 HELSINN CHEMICALS SA (4)

    04 HELSINN THERAPEUTICS US INC (2)

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    01 Switzerland (16)

    02 U.S.A (2)

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    01 Active (9)

    02 Inactive (9)

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    01 Complete (1)

    02 Blank (17)

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    ADAPALENE

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    HAS HEALTHCARE ADVANC...
    Active
    18826
    N/A
    2005-09-30
    II
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    ANAMORELIN HYDROCHLORIDE (API)

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    HELSINN THERAPEUTICS ...
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    31120
    N/A
    2016-11-16
    II
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    ANAMORELIN HYDROCHLORIDE, 100 MG TA...

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    HELSINN THERAPEUTICS ...
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    30961
    N/A
    2016-11-16
    II
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    CHLORZOXAZONE DRUG SUBSTANCE

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    HELSINN CHEMICALS SA
    Inactive
    6518
    N/A
    1986-04-11
    II
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    DANTROLENE SODIUM DRUG SUBSTANCE

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    HAS HEALTHCARE ADVANC...
    Active
    19498
    N/A
    2006-06-01
    II
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    DMSAM

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    HAS HEALTHCARE ADVANC...
    Inactive
    17801
    N/A
    2004-10-29
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    FOSNETUPITANT CHLORIDE

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    HAS HEALTHCARE ADVANC...
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    31323
    N/A
    2017-03-31
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    GUANABENZ ACETATE

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    HELSINN CHEMICALS SA
    Inactive
    5897
    N/A
    1985-06-10
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    ISOTRETINOIN

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    HAS HEALTHCARE ADVANC...
    Active
    19918
    Complete
    2013-05-09
    2012-12-14
    2006-10-30
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    MELATONIN

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    HELSINN CHEMICALS SA
    Inactive
    11575
    N/A
    1995-07-04
    II
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