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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Par Pharmaceutical Inc

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    300 Tice BoulevardWoodcliff Lake, NJ 07677
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    Alprazolam

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    USDMF

    Found USDMF

    18075
    Active
    ALPRAZOLAM DRUG SUBSTANCE
    2005-02-06
    CEP/COS

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    Application Number
    18075
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ALPRAZOLAM DRUG SUBSTANCE
    Issue/Submission Date
    2005-02-06
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    Atorvastatin

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    USDMF

    Found USDMF

    24532
    Active
    ATORVASTATIN CALCIUM AMORPHOUS (NON...
    2011-01-06
    CEP/COS

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    Application Number
    24532
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ATORVASTATIN CALCIUM AMORPHOUS (NON...
    Issue/Submission Date
    2011-01-06
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    Clonazepam

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    USDMF

    Found USDMF

    16245
    Active
    CLONAZEPAM
    2002-11-15
    CEP/COS

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    Application Number
    16245
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLONAZEPAM
    Issue/Submission Date
    2002-11-15
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    Colchicine

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    USDMF

    Found USDMF

    27722
    Active
    COLCHICINE USP
    2013-12-06
    CEP/COS

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    Application Number
    27722
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    COLCHICINE USP
    Issue/Submission Date
    2013-12-06
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    Darifenacin Hydrobromide

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    USDMF

    Found USDMF

    23269
    Active
    DARIFENACIN HYDROBROMIDE (NON STERI...
    2009-11-12
    CEP/COS

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    Application Number
    23269
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DARIFENACIN HYDROBROMIDE (NON STERI...
    Issue/Submission Date
    2009-11-12
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    Levofloxacin

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    USDMF

    Found USDMF

    23382
    Active
    LEVOFLOXACIN HEMIHYDRATE (NON-STERI...
    2009-12-17
    CEP/COS

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    Application Number
    23382
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVOFLOXACIN HEMIHYDRATE (NON-STERI...
    Issue/Submission Date
    2009-12-17
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    Midodrine

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    USDMF

    Found USDMF

    28211
    Active
    MIDODRINE HYDROCHLORIDE USP
    2014-04-30
    CEP/COS

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    Japanese DMF

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    Application Number
    28211
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIDODRINE HYDROCHLORIDE USP
    Issue/Submission Date
    2014-04-30
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    Molindone

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    USDMF

    Found USDMF

    19448
    Active
    MOLINDONE HYDROCHLORIDE
    2006-05-18
    CEP/COS

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    Japanese DMF

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    Application Number
    19448
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MOLINDONE HYDROCHLORIDE
    Issue/Submission Date
    2006-05-18
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    Nisoldipine

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    USDMF

    Found USDMF

    21106
    Active
    NISOLDIPINE NON STERILE BULK DRUG S...
    2007-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    21106
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NISOLDIPINE NON STERILE BULK DRUG S...
    Issue/Submission Date
    2007-11-03
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    Paliperidone

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    USDMF

    Found USDMF

    23830
    Active
    PALIPERIDONE (NON-STERILE BULK DRUG...
    2010-05-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    23830
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PALIPERIDONE (NON-STERILE BULK DRUG...
    Issue/Submission Date
    2010-05-24
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    Phenoxybenzamine HCl

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    USDMF

    Found USDMF

    25580
    Active
    PHENOXYBENZAMINE HYDROCHLORIDE USP
    2012-01-11
    CEP/COS

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    Japanese DMF

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    Application Number
    25580
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PHENOXYBENZAMINE HYDROCHLORIDE USP
    Issue/Submission Date
    2012-01-11
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    Pimozide

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    USDMF

    Found USDMF

    25462
    Active
    PIMOZIDE USP
    2011-12-14
    CEP/COS

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    Japanese DMF

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    Application Number
    25462
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIMOZIDE USP
    Issue/Submission Date
    2011-12-14
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    Pioglitazone Hydrochloride

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    USDMF

    Found USDMF

    22924
    Active
    PIOGLITAZONE HYDROCHLORIDE (NON-STE...
    2009-07-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    22924
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE (NON-STE...
    Issue/Submission Date
    2009-07-06
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    Pramipexole Dihydrochloride

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    USDMF

    Found USDMF

    22209
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE USP (NO...
    2008-11-17
    CEP/COS

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    Application Number
    22209
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE USP (NO...
    Issue/Submission Date
    2008-11-17
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    21386
    Active
    QUETIAPINE HEMIFUMARATE (NON-STERIL...
    2008-02-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    21386
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    QUETIAPINE HEMIFUMARATE (NON-STERIL...
    Issue/Submission Date
    2008-02-29
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    Ranolazine

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    USDMF

    Found USDMF

    23401
    Active
    RANOLAZINE (NON-STERILE BULK DRUG S...
    2009-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    23401
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RANOLAZINE (NON-STERILE BULK DRUG S...
    Issue/Submission Date
    2009-12-23
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    Rasagiline Mesylate

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    USDMF

    Found USDMF

    22782
    Active
    RASAGILINE MESYLATE (NON STERILE BU...
    2009-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    22782
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RASAGILINE MESYLATE (NON STERILE BU...
    Issue/Submission Date
    2009-05-15
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    Rosiglitazone Maleate

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    USDMF

    Found USDMF

    23381
    Active
    ROSIGLITAZONE MALEATE (NON-STERILE ...
    2009-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23381
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ROSIGLITAZONE MALEATE (NON-STERILE ...
    Issue/Submission Date
    2009-12-17
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    Sildenafil Citrate

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    USDMF

    Found USDMF

    23067
    Active
    SILDENAFIL CITRATE (NON-STERILE BUL...
    2009-08-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    23067
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SILDENAFIL CITRATE (NON-STERILE BUL...
    Issue/Submission Date
    2009-08-21
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    Tizanidine HCl

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    USDMF

    Found USDMF

    28176
    Active
    TIZANIDINE HYDROCHLORIDE, USP
    2014-04-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    28176
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TIZANIDINE HYDROCHLORIDE, USP
    Issue/Submission Date
    2014-04-18
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    Tolcapone

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    USDMF

    Found USDMF

    25857
    Active
    TOLCAPONE, USP
    2012-06-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    25857
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TOLCAPONE, USP
    Issue/Submission Date
    2012-06-13
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    FACILITIES AND CONTROLS

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    USDMF

    Caution USDMF

    3441
    Inactive
    FACILITIES AND CONTROLS
    1979-02-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    3441
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITIES AND CONTROLS
    Issue/Submission Date
    1979-02-09
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    5963
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1985-08-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5963
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1985-08-08
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