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

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    Helsinn Advanced Synthesis
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    Switzerland
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    Via Industria 246710 Biasca – Switzerland
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    +41 (0) 91 873.94.00
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    ADAPALENE

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    HAS HEALTHCARE ADVANC...
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    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...
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    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
    II
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    FOSNETUPITANT CHLORIDE

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

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

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

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

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    HAS HEALTHCARE ADVANC...
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    17815
    N/A
    2004-11-10
    II
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    NETUPITANT

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    HAS HEALTHCARE ADVANC...
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    26715
    N/A
    2013-07-19
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    PALONOSETRON HYDROCHLORIDE USP

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    HAS HEALTHCARE ADVANC...
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    16063
    N/A
    2002-07-19
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    PYRIDOSTIGMINE BROMIDE

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    HELSINN ADVANCED SYNT...
    Inactive
    10877
    N/A
    1994-04-11
    II
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    SODIUM BENZOATE

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    HELSINN ADVANCED SYNT...
    Inactive
    19426
    N/A
    2006-05-12
    II
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    TRAMADOL HYDROCHLORIDE

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    HELSINN CHEMICALS SA
    Inactive
    11605
    N/A
    1995-07-28
    II
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    TRIFAROTENE

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    HAS HEALTHCARE ADVANC...
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    32486
    N/A
    2018-07-16
    II
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    TROSPIUM CHLORIDE

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    HAS HEALTHCARE ADVANC...
    Inactive
    18544
    N/A
    2005-07-29
    II
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