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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Piramal Pharma Solutions

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    Piramal Pharma Solutions
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    18655 Krause St, Riverview, MI 48193
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    +1 734 282 3370
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    • FDA
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    Diltiazem Hydrochloride

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    USDMF

    Found USDMF

    14713
    Active
    DILTIAZEM HYDROCHLORIDE USP
    2000-01-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-121 - Rev 14
    Valid
    Diltiazem hydrochloride
    2022-01-07
    Japanese DMF

    Found JDMF

    221MF10252
    Diltiazem Hydrochloride at Digwal V...
    2009-11-24
    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Diltiazem Hydrochloride (1P/BP/Ph. ...
    2022-06-29
    Application Number
    14713
    R1-CEP 1997-121 - Rev 14
    221MF10252
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DILTIAZEM HYDROCHLORIDE USP
    Diltiazem hydrochloride
    Diltiazem Hydrochloride at Digwal V...
    Diltiazem Hydrochloride (1P/BP/Ph. ...
    Issue/Submission Date
    2000-01-27
    2022-01-07
    2009-11-24
    2022-06-29
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    • FDA
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    Ketoconazole

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    USDMF

    Found USDMF

    17290
    Active
    KETOCONAZOLE
    2004-04-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-049 - Rev 10
    Valid
    Ketoconazole
    2022-01-07
    Japanese DMF

    Found JDMF

    303MF10100
    Japanese Pharmacopoeia ketoconazole...
    2021-07-02
    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Ketoconazole (IP/BP/Ph. Eur./USP)
    2022-06-29
    Application Number
    17290
    R1-CEP 1999-049 - Rev 10
    303MF10100
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    KETOCONAZOLE
    Ketoconazole
    Japanese Pharmacopoeia ketoconazole...
    Ketoconazole (IP/BP/Ph. Eur./USP)
    Issue/Submission Date
    2004-04-02
    2022-01-07
    2021-07-02
    2022-06-29
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    Amiodarone Hydrochloride

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    USDMF

    Found USDMF

    21694
    Active
    AMIODARONE HYDROCHLORIDE
    2008-06-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-291 - Rev 03
    Valid
    Amiodarone hydrochloride
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Amiodarone Hydrochloride (Ph. Eur.)
    2022-06-29
    Application Number
    21694
    R1-CEP 2009-291 - Rev 03
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    AMIODARONE HYDROCHLORIDE
    Amiodarone hydrochloride
    Amiodarone Hydrochloride (Ph. Eur.)
    Issue/Submission Date
    2008-06-12
    2022-01-07
    2022-06-29
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    Aprepitant

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    USDMF

    Found USDMF

    26065
    Active
    APREPITANT
    2012-05-11
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-192 - Rev 02
    Valid
    Aprepitant
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Aprepitant (IH)
    2022-06-29
    Application Number
    26065
    R0-CEP 2017-192 - Rev 02
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    APREPITANT
    Aprepitant
    Aprepitant (IH)
    Issue/Submission Date
    2012-05-11
    2022-01-07
    2022-06-29
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    • FDA
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    Baclofen

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    USDMF

    Found USDMF

    28455
    Active
    BACLOFEN
    2014-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-313 - Rev 00
    Valid
    Baclofen
    2023-07-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Baclofen USP/EP
    2022-06-29
    Application Number
    28455
    R1-CEP 2016-313 - Rev 00
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    BACLOFEN
    Baclofen
    Baclofen USP/EP
    Issue/Submission Date
    2014-07-31
    2023-07-04
    2022-06-29
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    Bisoprolol Fumarate

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    USDMF

    Found USDMF

    29123
    Active
    BISOPROLOL FUMARATE
    2015-03-26
    CEP/COS

    Found CEP/COS

    CEP 2015-127 - Rev 01
    Valid
    Bisoprolol fumarate
    2024-03-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Bisoprolol Fumarate (BP/Ph.Eur/USP)
    2022-06-29
    Application Number
    29123
    CEP 2015-127 - Rev 01
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    BISOPROLOL FUMARATE
    Bisoprolol fumarate
    Bisoprolol Fumarate (BP/Ph.Eur/USP)
    Issue/Submission Date
    2015-03-26
    2024-03-05
    2022-06-29
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    Entacapone

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    USDMF

    Found USDMF

    29010
    Active
    ENTACAPONE
    2015-03-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-051 - Rev 01
    Valid
    Entacapone
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Entacapone (BP/Ph. Eur/USP)
    2022-06-29
    Application Number
    29010
    R1-CEP 2015-051 - Rev 01
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ENTACAPONE
    Entacapone
    Entacapone (BP/Ph. Eur/USP)
    Issue/Submission Date
    2015-03-13
    2022-01-07
    2022-06-29
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    Fosaprepitant

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    USDMF

    Found USDMF

    31484
    Active
    FOSAPREPITANT DIMEGLUMINE
    2017-03-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10083
    Fosaprepitant meglumine at Digwal V...
    2020-07-16
    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Fosaprepitant Dimeglumine IH
    2022-06-29
    Application Number
    31484
    302MF10083
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    FOSAPREPITANT DIMEGLUMINE
    Fosaprepitant meglumine at Digwal V...
    Fosaprepitant Dimeglumine IH
    Issue/Submission Date
    2017-03-20
    2020-07-16
    2022-06-29
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    Perindopril Erbumine

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    USDMF

    Found USDMF

    28144
    Active
    PERINDOPRIL ERBUMINE
    2014-03-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2014-112 - Rev 03
    Valid
    Perindopril tert-butylamine
    2020-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Perindoperil tert-butylamine (BP/Ph...
    2022-06-29
    Application Number
    28144
    R0-CEP 2014-112 - Rev 03
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PERINDOPRIL ERBUMINE
    Perindopril tert-butylamine
    Perindoperil tert-butylamine (BP/Ph...
    Issue/Submission Date
    2014-03-29
    2020-11-20
    2022-06-29
    ASK
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    Pramipexole Dihydrochloride

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    USDMF

    Found USDMF

    30186
    Active
    PRAMIPEXOL DIHYDROCHLORIDE
    2016-03-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-313 - Rev 01
    Valid
    Pramipexole dihydrochloride monohyd...
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Pramipexole Dihydrochloride (BP/Ph....
    2022-06-29
    Application Number
    30186
    R1-CEP 2014-313 - Rev 01
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PRAMIPEXOL DIHYDROCHLORIDE
    Pramipexole dihydrochloride monohyd...
    Pramipexole Dihydrochloride (BP/Ph....
    Issue/Submission Date
    2016-03-07
    2022-01-07
    2022-06-29
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    Trazodone Hydrochloride

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    USDMF

    Found USDMF

    20920
    Active
    TRAZODONE HYDROCHLORIDE
    2007-10-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-166 - Rev 00
    Valid
    Trazodone hydrochloride
    2023-08-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Trazodone Hydrochloride (BP/USP
    2022-06-29
    Application Number
    20920
    R0-CEP 2022-166 - Rev 00
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TRAZODONE HYDROCHLORIDE
    Trazodone hydrochloride
    Trazodone Hydrochloride (BP/USP
    Issue/Submission Date
    2007-10-04
    2023-08-01
    2022-06-29
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    • FDA
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    Verapamil Hydrochloride

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    USDMF

    Found USDMF

    16605
    Active
    VERAPAMIL HYDROCHLORIDE
    2003-05-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-071 - Rev 01
    Valid
    Verapamil hydrochloride, Process B
    2020-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Verapamil Hydrochloride (IP/BP/Ph. ...
    2022-06-29
    Application Number
    16605
    R1-CEP 2012-071 - Rev 01
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VERAPAMIL HYDROCHLORIDE
    Verapamil hydrochloride, Process B
    Verapamil Hydrochloride (IP/BP/Ph. ...
    Issue/Submission Date
    2003-05-26
    2020-11-20
    2022-06-29
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    Desmopressin Acetate

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    USDMF

    Found USDMF

    22871
    Active
    DESMOPRESSIN ACETATE
    2009-06-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-087 - Rev 02
    Valid
    Desmopressin
    2022-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Desmopressin (BP/Ph. Eur.)
    2019-09-03
    Application Number
    22871
    R1-CEP 2009-087 - Rev 02
    Indian CDSCO WC-0237
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-02
    Filing Details
    DESMOPRESSIN ACETATE
    Desmopressin
    Desmopressin (BP/Ph. Eur.)
    Issue/Submission Date
    2009-06-16
    2022-10-04
    2019-09-03
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    Oxytocin

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    USDMF

    Found USDMF

    26517
    Active
    OXYTOCIN
    2012-09-22
    CEP/COS

    Found CEP/COS

    CEP 2008-029 - Rev 04
    Valid
    Oxytocin
    2023-11-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Oxytocin Powder (BP/Ph. Eur.) / Oxy...
    2019-09-03
    Application Number
    26517
    CEP 2008-029 - Rev 04
    Indian CDSCO WC-0237
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-09-02
    Filing Details
    OXYTOCIN
    Oxytocin
    Oxytocin Powder (BP/Ph. Eur.) / Oxy...
    Issue/Submission Date
    2012-09-22
    2023-11-03
    2019-09-03
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    Aciclovir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25389
    Active
    ACYCLOVIR
    2011-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Acyclovir USP
    2022-06-29
    Application Number
    25389
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ACYCLOVIR
    Acyclovir USP
    Issue/Submission Date
    2011-09-29
    2022-06-29
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    Armodafinil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30405
    Active
    ARMODAFINIL
    2016-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Armodafinil IH
    2022-06-29
    Application Number
    30405
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    ARMODAFINIL
    Armodafinil IH
    Issue/Submission Date
    2016-03-31
    2022-06-29
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    Brimonidine Tartrate

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    USDMF

    Found USDMF

    17588
    Active
    BRIMONIDINE TARTRATE
    2004-08-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10073
    Brimonidine tartrate at Digwal Vill...
    2010-02-25
    Written Confirmation

    Close WC

    Application Number
    17588
    222MF10073
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BRIMONIDINE TARTRATE
    Brimonidine tartrate at Digwal Vill...
    Issue/Submission Date
    2004-08-05
    2010-02-25
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    Brimonidine Tartrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-052 - Rev 01
    Valid
    Brimonidine tartrate
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Brimonidine Tartrate (IH/Ph. Eur.)
    2022-06-29
    Application Number
    R1-CEP 2015-052 - Rev 01
    Indian CDSCO WC-0123
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Brimonidine tartrate
    Brimonidine Tartrate (IH/Ph. Eur.)
    Issue/Submission Date
    2022-01-07
    2022-06-29
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    Cinacalcet Hydrochloride

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    USDMF

    Found USDMF

    29162
    Active
    CINACALCET HYDROCHLORIDE
    2015-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Cinacalcet Hydrochloride (IH)
    2022-06-29
    Application Number
    29162
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    CINACALCET HYDROCHLORIDE
    Cinacalcet Hydrochloride (IH)
    Issue/Submission Date
    2015-03-25
    2022-06-29
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    Clobazam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29164
    Active
    CLOBAZAM
    2015-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Clobazam (BP/Ph.Eur./IP/IH)
    2022-06-29
    Application Number
    29164
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    CLOBAZAM
    Clobazam (BP/Ph.Eur./IP/IH)
    Issue/Submission Date
    2015-03-28
    2022-06-29
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    • FDA
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    Dabigatran Etexilate Mesylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30404
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2016-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Dabigatran Etexilate Mesylate IH
    2022-06-29
    Application Number
    30404
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Dabigatran Etexilate Mesylate IH
    Issue/Submission Date
    2016-03-31
    2022-06-29
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    • FDA
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    Deferasirox

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    USDMF

    Found USDMF

    31485
    Active
    DEFERASIROX
    2017-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Deferasirox IH
    2022-06-29
    Application Number
    31485
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    DEFERASIROX
    Deferasirox IH
    Issue/Submission Date
    2017-03-29
    2022-06-29
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    • FDA
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    Donepezil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27650
    Active
    DONEPEZIL HYDROCHLORIDE
    2014-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Donepezil Hydrochloride (IP/USP)
    2022-06-29
    Application Number
    27650
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    DONEPEZIL HYDROCHLORIDE
    Donepezil Hydrochloride (IP/USP)
    Issue/Submission Date
    2014-03-03
    2022-06-29
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    • FDA
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    Flecainide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2017-106 - Rev 00
    Valid
    Flecainide acetate, Piramal site
    2022-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Flecainide Acetate (Ph. Eur./USP)
    2022-06-29
    Application Number
    R1-CEP 2017-106 - Rev 00
    Indian CDSCO WC-0123
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Flecainide acetate, Piramal site
    Flecainide Acetate (Ph. Eur./USP)
    Issue/Submission Date
    2022-10-28
    2022-06-29
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    • FDA
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    Levobunolol

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    USDMF

    Found USDMF

    16904
    Active
    LEVOBUNOLOL HYDROCHLORIDE
    2003-10-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Levobunolol Hydrochloride (BP/Ph. E...
    2022-06-29
    Application Number
    16904
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    LEVOBUNOLOL HYDROCHLORIDE
    Levobunolol Hydrochloride (BP/Ph. E...
    Issue/Submission Date
    2003-10-16
    2022-06-29
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    your Marketing & Sales content
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    • FDA
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    Lurasidone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29163
    Active
    LURASIDONE HYDROCHLORIDE
    2015-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Lurasidone HCl IH
    2022-06-29
    Application Number
    29163
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Lurasidone HCl IH
    Issue/Submission Date
    2015-03-30
    2022-06-29
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    • FDA
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    Mebeverine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-271 - Rev 03
    Valid
    Mebeverine hydrochloride
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Mebeverine Hydrochloride (BP)
    2022-06-29
    Application Number
    R0-CEP 2019-271 - Rev 03
    Indian CDSCO WC-0123
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Mebeverine hydrochloride
    Mebeverine Hydrochloride (BP)
    Issue/Submission Date
    2022-01-07
    2022-06-29
    ASK
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    • FDA
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    Misoprostol

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    USDMF

    Found USDMF

    21188
    Active
    MISOPROSTOL DISPERSION
    2007-12-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-121 - Rev 01
    Valid
    Misoprostol
    2017-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21188
    R1-CEP 2010-121 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MISOPROSTOL DISPERSION
    Misoprostol
    Issue/Submission Date
    2007-12-12
    2017-01-20
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    • FDA
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    Oxybutynin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-150 - Rev 04
    Valid
    Oxybutynin hydrochloride
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Oxybutynin Hydrochloride (IP/BP/USP...
    2022-06-29
    Application Number
    R1-CEP 2006-150 - Rev 04
    Indian CDSCO WC-0123
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Oxybutynin hydrochloride
    Oxybutynin Hydrochloride (IP/BP/USP...
    Issue/Submission Date
    2022-01-07
    2022-06-29
    ASK
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    your Marketing & Sales content
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    • FDA
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    Paliperidone Palmitate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32599
    Active
    PALIPERIDONE PALMITATE
    2018-04-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Paliperidone Palmitate IH
    2022-06-29
    Application Number
    32599
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    PALIPERIDONE PALMITATE
    Paliperidone Palmitate IH
    Issue/Submission Date
    2018-04-02
    2022-06-29
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    • FDA
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    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30403
    Active
    RIVAROXABAN
    2016-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Rivaroxaban IH
    2022-06-29
    Application Number
    30403
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    RIVAROXABAN
    Rivaroxaban IH
    Issue/Submission Date
    2016-03-31
    2022-06-29
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    • FDA
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    Sulindac

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26004
    Active
    SULINDAC
    2012-04-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Sulindac (USP/Ph.Eur)
    2022-06-29
    Application Number
    26004
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    SULINDAC
    Sulindac (USP/Ph.Eur)
    Issue/Submission Date
    2012-04-20
    2022-06-29
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    • FDA
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    Tetrabenazine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32450
    Active
    TETRABENAZINE
    2018-01-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Tetrabenzaine IH
    2022-06-29
    Application Number
    32450
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    TETRABENAZINE
    Tetrabenzaine IH
    Issue/Submission Date
    2018-01-17
    2022-06-29
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    • FDA
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    Tramadol Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    24954
    Active
    TRAMADOL HYDROCHLORIDE
    2011-05-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Tramadol Hydrochloride (IP/BP)
    2022-06-29
    Application Number
    24954
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Tramadol Hydrochloride (IP/BP)
    Issue/Submission Date
    2011-05-06
    2022-06-29
    ASK
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    your Marketing & Sales content
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    • FDA
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    Valacyclovir Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    26546
    Active
    VALACYCLOVIR HYDROCHLORIDE
    2012-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0123
    Valid
    Valacyclovir HCl USP
    2022-06-29
    Application Number
    26546
    Indian CDSCO WC-0123
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE
    Valacyclovir HCl USP
    Issue/Submission Date
    2012-09-25
    2022-06-29
    ASK
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    • FDA
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    Buserelin Acetate

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-308 - Rev 01
    Valid
    Buserelin
    2022-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Buserelin (Ph.Eur.)
    2019-09-03
    Application Number
    R1-CEP 2013-308 - Rev 01
    Indian CDSCO WC-0237
    Status
    Valid
     
    Expired
    2022-09-02
    Filing Details
    Buserelin
    Buserelin (Ph.Eur.)
    Issue/Submission Date
    2022-10-04
    2019-09-03
    ASK
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    • FDA
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    Calcitonin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-236 - Rev 01
    Valid
    Calcitonin (salmon), Synthetic
    2022-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Calcitonin BP/EP
    2019-09-03
    Application Number
    R1-CEP 2012-236 - Rev 01
    Indian CDSCO WC-0237
    Status
    Valid
     
    Expired
    2022-09-02
    Filing Details
    Calcitonin (salmon), Synthetic
    Calcitonin BP/EP
    Issue/Submission Date
    2022-10-04
    2019-09-03
    ASK
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    • FDA
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    Cetrorelix Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    34552
    Active
    CETRORELIX
    2020-03-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Cetrorelix (IH)
    2019-09-03
    Application Number
    34552
    Indian CDSCO WC-0237
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-09-02
    Filing Details
    CETRORELIX
    Cetrorelix (IH)
    Issue/Submission Date
    2020-03-19
    2019-09-03
    ASK
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    • FDA
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    Leuprolide Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25128
    Active
    LEUPROLIDE ACETATE
    2011-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Leuproreline BP/EP
    2019-09-03
    Application Number
    25128
    Indian CDSCO WC-0237
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-09-02
    Filing Details
    LEUPROLIDE ACETATE
    Leuproreline BP/EP
    Issue/Submission Date
    2011-06-30
    2019-09-03
    ASK
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    • FDA
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    Somatostatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-008 - Rev 02
    Valid
    Somatostatin
    2022-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Somatostatin (Ph. Eur.)
    2019-09-03
    Application Number
    R1-CEP 2011-008 - Rev 02
    Indian CDSCO WC-0237
    Status
    Valid
     
    Expired
    2022-09-02
    Filing Details
    Somatostatin
    Somatostatin (Ph. Eur.)
    Issue/Submission Date
    2022-10-04
    2019-09-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Terlipressin Acetate

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-470 - Rev 00
    Valid
    Terlipressin
    2022-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0237
    Expired
    Terlipressin (IH)
    2019-09-03
    Application Number
    R0-CEP 2021-470 - Rev 00
    Indian CDSCO WC-0237
    Status
    Valid
     
    Expired
    2022-09-02
    Filing Details
    Terlipressin
    Terlipressin (IH)
    Issue/Submission Date
    2022-12-06
    2019-09-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Cloprostenol Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15758
    Active
    CLOPROSTENOL SODIUM
    2001-11-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15758
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLOPROSTENOL SODIUM
    Issue/Submission Date
    2001-11-27
    ASK
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    • FDA
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    Desflurane

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

    See Less

    USDMF

    Found USDMF

    21111
    Active
    DESFLURANE USP
    2007-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21111
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DESFLURANE USP
    Issue/Submission Date
    2007-12-06
    ASK
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    • FDA
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    Gemfibrozil

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

    See Less

    USDMF

    Found USDMF

    20437
    Active
    GEIBROZIL
    2007-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    20437
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GEIBROZIL
    Issue/Submission Date
    2007-04-11
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    Irbesartan

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    USDMF

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    26684
    Active
    IRBESARTAN
    2012-12-04
    CEP/COS

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    Application Number
    26684
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IRBESARTAN
    Issue/Submission Date
    2012-12-04
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    Metaxalone

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    USDMF

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    27105
    Active
    METAXALONE
    2013-04-26
    CEP/COS

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    Application Number
    27105
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METAXALONE
    Issue/Submission Date
    2013-04-26
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    Norprostol

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    USDMF

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    30315
    Active
    NORPROSTOL
    2016-04-15
    CEP/COS

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    Application Number
    30315
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NORPROSTOL
    Issue/Submission Date
    2016-04-15
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    Pregabalin

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    USDMF

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    28396
    Active
    PREGABALIN
    2014-06-30
    CEP/COS

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    Application Number
    28396
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PREGABALIN
    Issue/Submission Date
    2014-06-30
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    Quetiapine Hemifumarate

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    USDMF

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    24816
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    QUETIAPINE FUMARATE
    2011-03-28
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    Application Number
    24816
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    QUETIAPINE FUMARATE
    Issue/Submission Date
    2011-03-28
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    Tolcapone

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    USDMF

    Found USDMF

    24989
    Active
    TOLCAPONE
    2011-05-26
    CEP/COS

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    Application Number
    24989
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TOLCAPONE
    Issue/Submission Date
    2011-05-26
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