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    • FDA
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    Allopurinol

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    USDMF

    Found USDMF

    15841
    Active
    ALLOPURINOL USP
    2002-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-335 - Rev 03
    Valid
    Allopurinol
    2021-03-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15841
    R1-CEP 2001-335 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ALLOPURINOL USP
    Allopurinol
    Issue/Submission Date
    2002-02-04
    2021-03-05
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    Pirfenidone

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    USDMF

    Found USDMF

    15168
    Active
    PIRFENIDONE EP
    2000-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10130
    Pirfenidone at Av. Industria Automo...
    2008-05-20
    Written Confirmation

    Close WC

    Application Number
    15168
    220MF10130
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIRFENIDONE EP
    Pirfenidone at Av. Industria Automo...
    Issue/Submission Date
    2000-11-30
    2008-05-20
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    Abacavir Sulfate

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    USDMF

    Found USDMF

    23644
    Active
    ABACAVIR SULFATE USP
    2010-03-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23644
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ABACAVIR SULFATE USP
    Issue/Submission Date
    2010-03-19
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    Aciclovir

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    USDMF

    Found USDMF

    22949
    Active
    ACYCLOVIR USP
    2009-07-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22949
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ACYCLOVIR USP
    Issue/Submission Date
    2009-07-16
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    Atorvastatin

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    USDMF

    Found USDMF

    21574
    Active
    ATORVASTATIN CALCIUM PROPYLENE GLYC...
    2008-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21574
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ATORVASTATIN CALCIUM PROPYLENE GLYC...
    Issue/Submission Date
    2008-04-29
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    Balsalazide Disodium

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    USDMF

    Found USDMF

    18894
    Active
    BALSALAZIDE DISODIUM DIHYDRATE USP
    2005-10-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18894
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BALSALAZIDE DISODIUM DIHYDRATE USP
    Issue/Submission Date
    2005-10-21
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    Brexpiprazole

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    USDMF

    Found USDMF

    33560
    Active
    BREXPIPRAZOLE
    2019-03-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33560
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BREXPIPRAZOLE
    Issue/Submission Date
    2019-03-11
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    Clopidogrel

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    USDMF

    Found USDMF

    15721
    Active
    CLOPIDOGREL BISULPHATE USP
    2001-11-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15721
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLOPIDOGREL BISULPHATE USP
    Issue/Submission Date
    2001-11-13
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    Duloxetine

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    USDMF

    Found USDMF

    21833
    Active
    DULOXETINE HYDROCHLORIDE USP
    2008-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21833
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DULOXETINE HYDROCHLORIDE USP
    Issue/Submission Date
    2008-07-30
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    Famciclovir

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    USDMF

    Found USDMF

    22713
    Active
    FAMCICLOVIR USP
    2009-04-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22713
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FAMCICLOVIR USP
    Issue/Submission Date
    2009-04-09
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    Imatinib Mesylate

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    USDMF

    Caution USDMF

    28192
    Inactive
    IMATINIB MESYLATE
    2016-06-28
    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-251 - Rev 03
    Expired
    Imatinib mesilate
    2019-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28192
    R0-CEP 2015-251 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    IMATINIB MESYLATE
    Imatinib mesilate
    Issue/Submission Date
    2016-06-28
    2019-02-14
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    Irbesartan

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    USDMF

    Caution USDMF

    23347
    Inactive
    IRBESARTAN USP
    2009-12-07
    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-327 - Rev 03
    Withdrawn by Holder
    Irbesartan
    2020-01-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23347
    R1-CEP 2010-327 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Issue/Submission Date
    2009-12-07
    2020-01-08
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    Lacosamide

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    USDMF

    Found USDMF

    26484
    Active
    LACOSAMIDE
    2012-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26484
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LACOSAMIDE
    Issue/Submission Date
    2012-09-27
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    Lamivudine

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    USDMF

    Found USDMF

    22931
    Active
    LAMIVUDINE METHANOL SOLVATE USP
    2009-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22931
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LAMIVUDINE METHANOL SOLVATE USP
    Issue/Submission Date
    2009-07-08
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    Nadolol

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    USDMF

    Found USDMF

    7426
    Active
    NADOLOL USP
    1988-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7426
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NADOLOL USP
    Issue/Submission Date
    1988-04-11
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    Oxcarbazepine

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    USDMF

    Found USDMF

    17988
    Active
    OXCARBAZEPINE USP
    2005-01-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17988
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OXCARBAZEPINE USP
    Issue/Submission Date
    2005-01-12
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    • FDA
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    Paroxetine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28763
    Active
    PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
    2014-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28763
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
    Issue/Submission Date
    2014-12-22
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    Pazopanib Hydrochloride

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    USDMF

    Found USDMF

    34146
    Active
    PAZOPANIB HYDROCHLORIDE
    2019-11-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34146
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PAZOPANIB HYDROCHLORIDE
    Issue/Submission Date
    2019-11-01
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    Ponatinib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35413
    Active
    PONATINIB HYDROCHLORIDE
    2020-12-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35413
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PONATINIB HYDROCHLORIDE
    Issue/Submission Date
    2020-12-16
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    • FDA
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    Sitagliptin Phosphate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32298
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
    2018-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32298
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
    Issue/Submission Date
    2018-03-30
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    Terazosin HCl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18268
    Active
    TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
    2005-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18268
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
    Issue/Submission Date
    2005-04-11
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    Valsartan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23150
    Inactive
    VALSARTAN USP
    2009-10-05
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-231 - Rev 00
    Expired
    Valsartan
    2014-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23150
    R0-CEP 2011-231 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    VALSARTAN USP
    Valsartan
    Issue/Submission Date
    2009-10-05
    2014-06-24
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    Alendronate Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16129
    Inactive
    ALENDRONATE SODIUM TRIHYDRATE USP
    2002-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16129
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALENDRONATE SODIUM TRIHYDRATE USP
    Issue/Submission Date
    2002-09-10
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    Asenapine Maleate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    27316
    Inactive
    ASENAPINE MALEATE
    2013-07-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27316
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ASENAPINE MALEATE
    Issue/Submission Date
    2013-07-26
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    Atazanavir Sulfate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    28565
    Inactive
    ATAZANAVIR SULFATE
    2015-01-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28565
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ATAZANAVIR SULFATE
    Issue/Submission Date
    2015-01-28
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    30543
    Inactive
    CAPECITABINE USP
    2016-06-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30543
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CAPECITABINE USP
    Issue/Submission Date
    2016-06-23
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    Didanosine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17413
    Inactive
    DIDEOXYINOSINE
    2004-05-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17413
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DIDEOXYINOSINE
    Issue/Submission Date
    2004-05-26
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    Divalproex Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17224
    Inactive
    VALPROIC ACID USP
    2004-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17224
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    VALPROIC ACID USP
    Issue/Submission Date
    2004-03-05
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    Entacapone

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-055 - Rev 01
    Expired
    Entacapone
    2016-08-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2012-055 - Rev 01
    Status
    Expired
     
    Filing Details
    Entacapone
    Issue/Submission Date
    2016-08-09
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    Ezetimibe

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    26637
    Inactive
    EZETIMIBE USP
    2012-12-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26637
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    EZETIMIBE USP
    Issue/Submission Date
    2012-12-10
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    Fluconazole

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    USDMF

    Caution USDMF

    16420
    Inactive
    FLUCONAZOLE
    2003-02-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    16420
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FLUCONAZOLE
    Issue/Submission Date
    2003-02-10
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    Gatifloxacin

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    USDMF

    Caution USDMF

    30999
    Inactive
    GATIFLOXACIN HEMIHYDRATE
    2016-12-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30999
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GATIFLOXACIN HEMIHYDRATE
    Issue/Submission Date
    2016-12-27
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    Gemfibrozil

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    USDMF

    Caution USDMF

    15412
    Inactive
    GEIBROZIL USP
    2001-05-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    15412
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GEIBROZIL USP
    Issue/Submission Date
    2001-05-03
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    Gemfibrozil

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    USDMF

    Caution USDMF

    26146
    Inactive
    GEIBROZIL USP (GEA PROCESS)
    2011-04-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    26146
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GEIBROZIL USP (GEA PROCESS)
    Issue/Submission Date
    2011-04-18
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    Lanthanum Carbonate

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    USDMF

    Caution USDMF

    28008
    Inactive
    LANTHANUM CARBONATE HYDRATE
    2014-06-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28008
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LANTHANUM CARBONATE HYDRATE
    Issue/Submission Date
    2014-06-05
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    Levetiracetam

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    USDMF

    Caution USDMF

    20412
    Inactive
    LEVETIRACETAM USP
    2007-04-04
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    20412
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LEVETIRACETAM USP
    Issue/Submission Date
    2007-04-04
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    Mesalazine

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    USDMF

    Caution USDMF

    29676
    Inactive
    MESALAMINE USP
    2016-01-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29676
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MESALAMINE USP
    Issue/Submission Date
    2016-01-12
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    Methyldopa

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    USDMF

    Caution USDMF

    6363
    Inactive
    ALPHA METHYL DOPA USP
    1986-05-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    6363
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALPHA METHYL DOPA USP
    Issue/Submission Date
    1986-05-16
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    Metronidazole

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    USDMF

    Caution USDMF

    4025
    Inactive
    CRUDE METRONIDAZOLE
    1981-01-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    4025
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CRUDE METRONIDAZOLE
    Issue/Submission Date
    1981-01-06
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    Nefazodone Hydrochloride

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    USDMF

    Caution USDMF

    16387
    Inactive
    NEFAZODONE HYDROCHLORIDE
    2003-01-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16387
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NEFAZODONE HYDROCHLORIDE
    Issue/Submission Date
    2003-01-28
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    Pioglitazone Hydrochloride

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    USDMF

    Caution USDMF

    21603
    Inactive
    PIOGLITAZONE HYDROCHLORIDE USP
    2008-05-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    21603
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE USP
    Issue/Submission Date
    2008-05-08
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    Progesterone

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    USDMF

    Caution USDMF

    26640
    Inactive
    PROGESTERONE USP
    2012-12-21
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26640
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PROGESTERONE USP
    Issue/Submission Date
    2012-12-21
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    Quinapril

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    USDMF

    Caution USDMF

    15619
    Inactive
    QUINAPRIL HYDROCHLORIDE ACETONE SOL...
    2001-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    15619
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    QUINAPRIL HYDROCHLORIDE ACETONE SOL...
    Issue/Submission Date
    2001-09-14
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    Sildenafil Citrate

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    USDMF

    Caution USDMF

    22599
    Inactive
    SILDENAFIL CITRATE USP
    2009-03-06
    CEP/COS

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    Application Number
    22599
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SILDENAFIL CITRATE USP
    Issue/Submission Date
    2009-03-06
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    Sodium Valproate

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    USDMF

    Caution USDMF

    17225
    Inactive
    SODIUM VALPROATE
    2004-03-05
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    17225
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM VALPROATE
    Issue/Submission Date
    2004-03-05
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    Telmisartan

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    USDMF

    Caution USDMF

    25742
    Inactive
    TELMISARTAN USP/EP
    2012-01-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    25742
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TELMISARTAN USP/EP
    Issue/Submission Date
    2012-01-25
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    Tiagabine Hydrochloride

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    USDMF

    Caution USDMF

    27380
    Inactive
    TIAGABINE HYDROCHLORIDE MONOHYDRATE...
    2013-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    27380
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TIAGABINE HYDROCHLORIDE MONOHYDRATE...
    Issue/Submission Date
    2013-12-20
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    Topiramate

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    USDMF

    Caution USDMF

    21657
    Inactive
    TOPIRAMATE USP
    2008-05-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    21657
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TOPIRAMATE USP
    Issue/Submission Date
    2008-05-26
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    Zidovudine

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    USDMF

    Caution USDMF

    8818
    Inactive
    AZT (ZIDOVUDINE)
    1990-11-07
    CEP/COS

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    Written Confirmation

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    Application Number
    8818
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AZT (ZIDOVUDINE)
    Issue/Submission Date
    1990-11-07
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