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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Wockhardt Limited

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    Wockhardt
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    India
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    Wockhardt Towers, Bandra Mumbai 400051 Maharashtra
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    Dextromethorphan Hydrobromide

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    USDMF

    Found USDMF

    11935
    Active
    DEXTROMETHORPHAN HYDROBROMIDE USP
    1996-04-18
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-053 - Rev 04
    Valid
    Dextromethorphan hydrobromide
    2017-03-21
    Japanese DMF

    Found JDMF

    303MF10152
    Dextromethorphan hydrobromic acid h...
    2021-09-28
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Dextromethorphan Hydrobromide (EP/B...
    2019-07-22
    Application Number
    11935
    R1-CEP 1998-053 - Rev 04
    303MF10152
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    DEXTROMETHORPHAN HYDROBROMIDE USP
    Dextromethorphan hydrobromide
    Dextromethorphan hydrobromic acid h...
    Dextromethorphan Hydrobromide (EP/B...
    Issue/Submission Date
    1996-04-18
    2017-03-21
    2021-09-28
    2019-07-22
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    Adenosine

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    USDMF

    Found USDMF

    20071
    Active
    ADENOSINE USP
    2007-05-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-258 - Rev 02
    Valid
    Adenosine
    2022-05-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Adenosine (EP/USP)
    2019-07-22
    Application Number
    20071
    R1-CEP 2008-258 - Rev 02
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    ADENOSINE USP
    Adenosine
    Adenosine (EP/USP)
    Issue/Submission Date
    2007-05-15
    2022-05-24
    2019-07-22
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    Tamsulosin

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    USDMF

    Found USDMF

    20095
    Active
    TAMSULOSIN HYDROCHLORIDE
    2006-12-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-234 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2014-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Tamsulosin Hydrochloride (EP)
    2019-07-22
    Application Number
    20095
    R1-CEP 2007-234 - Rev 00
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    TAMSULOSIN HYDROCHLORIDE
    Tamsulosin hydrochloride
    Tamsulosin Hydrochloride (EP)
    Issue/Submission Date
    2006-12-23
    2014-03-07
    2019-07-22
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    • FDA
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    Captopril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8028
    Active
    CAPTOPRIL
    1989-04-24
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-052 - Rev 04
    Valid
    Captopril
    2014-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8028
    R1-CEP 1998-052 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CAPTOPRIL
    Captopril
    Issue/Submission Date
    1989-04-24
    2014-06-24
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    Bethanechol

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    USDMF

    Found USDMF

    16119
    Active
    BETHANECHOL CHLORIDE USP
    2002-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Bethanecol Chloride (USP)
    2019-07-22
    Application Number
    16119
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    BETHANECHOL CHLORIDE USP
    Bethanecol Chloride (USP)
    Issue/Submission Date
    2002-08-27
    2019-07-22
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    Ceftriaxone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16650
    Active
    STERILE CEFTRIAXONE SODIUM USP
    2003-06-16
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-203 - Rev 01
    Withdrawn by Holder
    Ceftriaxone sodium, Sterile
    2011-05-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16650
    R1-CEP 2002-203 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    STERILE CEFTRIAXONE SODIUM USP
    Ceftriaxone sodium, Sterile
    Issue/Submission Date
    2003-06-16
    2011-05-23
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    Cefuroxime Axetil

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    USDMF

    Caution USDMF

    15411
    Inactive
    CEFUROXIME AXETIL(CRYSTALLINE) USP
    2001-05-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-051 - Rev 01
    Valid
    Cefuroxime axetil, Amorphous
    2009-12-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15411
    R1-CEP 2003-051 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFUROXIME AXETIL(CRYSTALLINE) USP
    Cefuroxime axetil, Amorphous
    Issue/Submission Date
    2001-05-01
    2009-12-17
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    Desvenlafaxine Succinate

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    USDMF

    Found USDMF

    25656
    Active
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    2012-01-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075a3
    Expired
    Desvenlafaxine Succinate Monohydrat...
    2020-10-16
    Application Number
    25656
    Indian CDSCO WC-0075a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    Desvenlafaxine Succinate Monohydrat...
    Issue/Submission Date
    2012-01-13
    2020-10-16
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    • FDA
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    Donepezil

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    USDMF

    Found USDMF

    21923
    Active
    DONEPEZIL HYDROCHLORIDE
    2008-08-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075a3
    Expired
    Donepezil HCl IH
    2020-10-16
    Application Number
    21923
    Indian CDSCO WC-0075a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    DONEPEZIL HYDROCHLORIDE
    Donepezil HCl IH
    Issue/Submission Date
    2008-08-29
    2020-10-16
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    Entacapone

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    USDMF

    Found USDMF

    19385
    Active
    ENTACAPONE USP
    2006-03-01
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-211 - Rev 00
    Withdrawn by Holder
    Entacapone
    2012-10-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19385
    R0-CEP 2011-211 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ENTACAPONE USP
    Entacapone
    Issue/Submission Date
    2006-03-01
    2012-10-15
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    Epinephrine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21213
    Active
    EPINEPHRINE USP
    2007-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075a3
    Expired
    Epinephrin USP
    2020-10-16
    Application Number
    21213
    Indian CDSCO WC-0075a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    EPINEPHRINE USP
    Epinephrin USP
    Issue/Submission Date
    2007-12-31
    2020-10-16
    ASK
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    Nicardipine Hydrochloride

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    USDMF

    Found USDMF

    21211
    Active
    NICARDIPINE HYDROCHLORIDE
    2007-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Nicardipine Hydrochloride (1H)
    2019-07-22
    Application Number
    21211
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    NICARDIPINE HYDROCHLORIDE
    Nicardipine Hydrochloride (1H)
    Issue/Submission Date
    2007-12-31
    2019-07-22
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    • FDA
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20763
    Active
    PANTOPRAZOLE SODIUM USP
    2007-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075a3
    Expired
    Pantoprazole Sodium USP
    2020-10-16
    Application Number
    20763
    Indian CDSCO WC-0075a3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-21
    Filing Details
    PANTOPRAZOLE SODIUM USP
    Pantoprazole Sodium USP
    Issue/Submission Date
    2007-07-31
    2020-10-16
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    Pramipexole Dihydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24781
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE USP
    2011-06-23
    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-149 - Rev 00
    Withdrawn by Holder
    Pramipexole dihydrochloride monohyd...
    2014-07-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24781
    R0-CEP 2012-149 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE USP
    Pramipexole dihydrochloride monohyd...
    Issue/Submission Date
    2011-06-23
    2014-07-15
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    • FDA
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    Alfuzosin HCl

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20439
    Active
    ALFUZOSIN HYDROCHLORIDE
    2007-04-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20439
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ALFUZOSIN HYDROCHLORIDE
    Issue/Submission Date
    2007-04-06
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    Aripiprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26743
    Active
    ARIPIPRAZOLE
    2013-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26743
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARIPIPRAZOLE
    Issue/Submission Date
    2013-02-26
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    Azithromycin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18073
    Active
    ANHYDROUS AZITHROMYCIN
    2005-02-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18073
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANHYDROUS AZITHROMYCIN
    Issue/Submission Date
    2005-02-11
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    Cefotaxime

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16839
    Inactive
    CEFOTAXIME SODIUM (STERILE)
    2003-09-09
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-182 - Rev 01
    Withdrawn by Holder
    Cefotaxime sodium, Sterile
    2011-04-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16839
    R1-CEP 2002-182 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CEFOTAXIME SODIUM (STERILE)
    Cefotaxime sodium, Sterile
    Issue/Submission Date
    2003-09-09
    2011-04-28
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    Cefuroxime Axetil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16267
    Active
    CEFUROXIME AXETIL (AMORPHOUS)
    2002-11-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16267
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFUROXIME AXETIL (AMORPHOUS)
    Issue/Submission Date
    2002-11-25
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    Cefuroxime Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16649
    Inactive
    CEFUROXIME SODIUM (STERILE)
    2003-06-16
    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-236 - Rev 00
    Withdrawn by Holder
    Cefuroxime sodium, Sterile
    2006-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16649
    R0-CEP 2003-236 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CEFUROXIME SODIUM (STERILE)
    Cefuroxime sodium, Sterile
    Issue/Submission Date
    2003-06-16
    2006-07-07
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    Chlorothiazide Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22602
    Active
    CHLOROTHIAZIDE SODIUM
    2009-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22602
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHLOROTHIAZIDE SODIUM
    Issue/Submission Date
    2009-02-27
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    Clopidogrel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19288
    Active
    CLOPIDOGREL BISULFATE USP (FORM-1)
    2006-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19288
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLOPIDOGREL BISULFATE USP (FORM-1)
    Issue/Submission Date
    2006-02-27
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    Dextromethorphan Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10108
    Dextromethorphan hydrobromide hydra...
    2008-04-11
    Written Confirmation

    Close WC

    Application Number
    220MF10108
    Status
     
    Filing Details
    Dextromethorphan hydrobromide hydra...
    Issue/Submission Date
    2008-04-11
    ASK
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    Divalproex Sodium

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    USDMF

    Found USDMF

    17469
    Active
    DIVALPROEX SODIUM
    2004-06-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17469
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIVALPROEX SODIUM
    Issue/Submission Date
    2004-06-21
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    Duloxetine

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    USDMF

    Found USDMF

    21604
    Active
    DULOXETINE HYDROCHLORIDE USP
    2008-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21604
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DULOXETINE HYDROCHLORIDE USP
    Issue/Submission Date
    2008-04-29
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    Enalapril Maleate

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    USDMF

    Caution USDMF

    12780
    Inactive
    ENALAPRIL MALEATE
    1997-12-10
    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-062 - Rev 00
    Expired
    Enalapril maleate
    2005-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12780
    R0-CEP 2001-062 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    ENALAPRIL MALEATE
    Enalapril maleate
    Issue/Submission Date
    1997-12-10
    2005-01-17
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    Eszopiclone

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    USDMF

    Found USDMF

    22164
    Active
    ESZOPICLONE
    2008-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22164
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ESZOPICLONE
    Issue/Submission Date
    2008-11-03
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    Felodipine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13255
    Inactive
    FELODIPINE
    1998-10-02
    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-105 - Rev 01
    Withdrawn by Holder
    Felodipine
    2007-10-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13255
    R1-CEP 2000-105 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    FELODIPINE
    Felodipine
    Issue/Submission Date
    1998-10-02
    2007-10-23
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    Fesoterodine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26507
    Active
    FESOTERODINE FUMARATE
    2012-10-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26507
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FESOTERODINE FUMARATE
    Issue/Submission Date
    2012-10-24
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    Fexofenadine Hydrochloride

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    USDMF

    Found USDMF

    19816
    Active
    FEXOFENADINE HYDROCHLORIDE
    2006-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19816
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FEXOFENADINE HYDROCHLORIDE
    Issue/Submission Date
    2006-09-29
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    Fosaprepitant

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    USDMF

    Found USDMF

    30137
    Active
    FOSAPREPITANT DIMEGLUMINE
    2015-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30137
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FOSAPREPITANT DIMEGLUMINE
    Issue/Submission Date
    2015-12-31
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    Granisetron Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19708
    Active
    GRANISETRON HYDROCHLORIDE
    2006-08-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19708
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GRANISETRON HYDROCHLORIDE
    Issue/Submission Date
    2006-08-21
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    Lansoprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21605
    Active
    LANSOPRAZOLE USP
    2008-04-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21605
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LANSOPRAZOLE USP
    Issue/Submission Date
    2008-04-23
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    Omeprazole

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    USDMF

    Caution USDMF

    14286
    Inactive
    OMEPRAZOLE
    1999-07-07
    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-378 - Rev 00
    Expired
    Omeprazole
    2005-03-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14286
    R0-CEP 2001-378 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Issue/Submission Date
    1999-07-07
    2005-03-02
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    Oxybutynin Hydrochloride

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    USDMF

    Caution USDMF

    16061
    Inactive
    OXYBUTYNIN CHLORIDE USP
    2002-07-22
    CEP/COS

    Caution CEP/COS

    R1-CEP 2003-020 - Rev 03
    Withdrawn by Holder
    Oxybutynin hydrochloride
    2011-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16061
    R1-CEP 2003-020 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    OXYBUTYNIN CHLORIDE USP
    Oxybutynin hydrochloride
    Issue/Submission Date
    2002-07-22
    2011-10-28
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    Paliperidone

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    USDMF

    Found USDMF

    28601
    Active
    PALIPERIDONE USP
    2014-10-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28601
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PALIPERIDONE USP
    Issue/Submission Date
    2014-10-07
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    Palonosetron

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30955
    Active
    PALONOSETRON HYDROCHLORIDE USP
    2016-10-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30955
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PALONOSETRON HYDROCHLORIDE USP
    Issue/Submission Date
    2016-10-19
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    Pioglitazone Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16793
    Active
    PIOGLITAZONE HYDROCHLORIDE
    2003-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16793
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE
    Issue/Submission Date
    2003-08-28
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    Ranitidine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    12552
    Inactive
    RANITIDINE HYDROCHLORIDE
    1997-06-19
    CEP/COS

    Caution CEP/COS

    R0-CEP 2000-168 - Rev 01
    Expired
    Ranitidine hydrochloride
    2005-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12552
    R0-CEP 2000-168 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    RANITIDINE HYDROCHLORIDE
    Ranitidine hydrochloride
    Issue/Submission Date
    1997-06-19
    2005-09-27
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    Regadenoson Monohydrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29185
    Active
    REGADENOSON (AMORPHOUS)
    2015-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29185
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    REGADENOSON (AMORPHOUS)
    Issue/Submission Date
    2015-03-31
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    Saxagliptin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27083
    Active
    SAXAGLIPTIN HYDROCHLORIDE
    2013-07-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27083
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SAXAGLIPTIN HYDROCHLORIDE
    Issue/Submission Date
    2013-07-17
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    Sitagliptin Phosphate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27084
    Active
    SITAGLIPTIN PHOSPHATE
    2013-05-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27084
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SITAGLIPTIN PHOSPHATE
    Issue/Submission Date
    2013-05-27
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    Valacyclovir Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21010
    Active
    VALACYCLOVIR HYDROCHLORIDE
    2007-10-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21010
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE
    Issue/Submission Date
    2007-10-26
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    Ziprasidone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    19503
    Active
    ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
    2006-05-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19503
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
    Issue/Submission Date
    2006-05-30
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    • FDA
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    Zoledronic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21011
    Active
    ZOLEDRONIC ACID MONOHYDRATE
    2007-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21011
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZOLEDRONIC ACID MONOHYDRATE
    Issue/Submission Date
    2007-10-31
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    Zolpidem Tartrate

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    USDMF

    Found USDMF

    19289
    Active
    ZOLPIDEM TARTRATE
    2006-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19289
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZOLPIDEM TARTRATE
    Issue/Submission Date
    2006-02-27
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    Zonisamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18059
    Active
    ZONISAMIDE USP
    2005-02-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18059
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZONISAMIDE USP
    Issue/Submission Date
    2005-02-07
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    Azithromycin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    14480
    Inactive
    AZITHROMYCIN USP
    1999-10-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14480
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AZITHROMYCIN USP
    Issue/Submission Date
    1999-10-14
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    Fluoxetine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    14289
    Inactive
    FLUOXETINE HYDROCHLORIDE
    1999-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14289
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FLUOXETINE HYDROCHLORIDE
    Issue/Submission Date
    1999-07-12
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    FACILITY AND OPERATING PROCEDURES IN CHIKALTHANA, AURAN...

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    10943
    Inactive
    FACILITY AND OPERATING PROCEDURES I...
    1994-06-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10943
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITY AND OPERATING PROCEDURES I...
    Issue/Submission Date
    1994-06-20
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