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

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    APIs // Active Pharmaceutical Ingredients

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    Par Pharmaceutical
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    300 Tice BoulevardWoodcliff Lake, NJ 07677
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    (201) 802 4000
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    • FDA
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    ALPRAZOLAM DRUG SUBSTANCE

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    PAR ACTIVE TECHNOLOGI...
    Active
    18075
    N/A
    2005-02-06
    II
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    ATORVASTATIN CALCIUM AMORPHOUS (NON...

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    PAR ACTIVE TECHNOLOGI...
    Active
    24532
    N/A
    2011-01-06
    II
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    CLONAZEPAM

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    PAR ACTIVE TECHNOLOGI...
    Active
    16245
    N/A
    2002-11-15
    II
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    COLCHICINE USP

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    PAR PHARMACEUTICAL IN...
    Active
    27722
    Complete
    2014-05-05
    2013-12-05
    2013-12-06
    II
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    DARIFENACIN HYDROBROMIDE (NON STERI...

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    PAR ACTIVE TECHNOLOGI...
    Active
    23269
    N/A
    2009-11-12
    II
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    LEVOFLOXACIN HEMIHYDRATE (NON-STERI...

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    PAR ACTIVE TECHNOLOGI...
    Active
    23382
    N/A
    2009-12-17
    II
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    MIDODRINE HYDROCHLORIDE USP

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    PAR PHARMACEUTICAL IN...
    Active
    28211
    Complete
    2014-07-01
    2014-04-29
    2014-04-30
    II
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    MOLINDONE HYDROCHLORIDE

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    PAR ACTIVE TECHNOLOGI...
    Active
    19448
    N/A
    2006-05-18
    II
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    NISOLDIPINE NON STERILE BULK DRUG S...

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    PAR ACTIVE TECHNOLOGI...
    Active
    21106
    N/A
    2007-11-03
    II
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    PALIPERIDONE (NON-STERILE BULK DRUG...

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    PAR ACTIVE TECHNOLOGI...
    Active
    23830
    N/A
    2010-05-24
    II
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    PHENOXYBENZAMINE HYDROCHLORIDE USP

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    PAR PHARMACEUTICAL IN...
    Active
    25580
    N/A
    2012-01-11
    II
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    PIMOZIDE USP

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    PAR PHARMACEUTICAL IN...
    Active
    25462
    N/A
    2011-12-14
    II
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    PIOGLITAZONE HYDROCHLORIDE (NON-STE...

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    PAR ACTIVE TECHNOLOGI...
    Active
    22924
    N/A
    2009-07-06
    II
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    PRAMIPEXOLE DIHYDROCHLORIDE USP (NO...

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    PAR ACTIVE TECHNOLOGI...
    Active
    22209
    N/A
    2008-11-17
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    • FDA
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    QUETIAPINE HEMIFUMARATE (NON-STERIL...

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    PAR ACTIVE TECHNOLOGI...
    Active
    21386
    N/A
    2008-02-29
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    • FDA
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    RANOLAZINE (NON-STERILE BULK DRUG S...

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    PAR ACTIVE TECHNOLOGI...
    Active
    23401
    N/A
    2009-12-23
    II
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    • FDA
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    RASAGILINE MESYLATE (NON STERILE BU...

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    PAR ACTIVE TECHNOLOGI...
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    22782
    N/A
    2009-05-15
    II
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    ROSIGLITAZONE MALEATE (NON-STERILE ...

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    PAR ACTIVE TECHNOLOGI...
    Active
    23381
    N/A
    2009-12-17
    II
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    SILDENAFIL CITRATE (NON-STERILE BUL...

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    PAR ACTIVE TECHNOLOGI...
    Active
    23067
    N/A
    2009-08-21
    II
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    TIZANIDINE HYDROCHLORIDE, USP

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    PAR PHARMACEUTICAL IN...
    Active
    28176
    Complete
    2014-07-07
    2014-04-10
    2014-04-18
    II
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    TOLCAPONE, USP

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    PAR PHARMACEUTICAL IN...
    Active
    25857
    N/A
    2012-06-13
    II
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    FACILITIES AND CONTROLS

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    PAR PHARMACEUTICAL IN...
    Inactive
    3441
    N/A
    1979-02-09
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    PAR PHARMACEUTICAL IN...
    Inactive
    5963
    N/A
    1985-08-08
    II
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