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    • FDA
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    Ketoprofen

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    USDMF

    Caution USDMF

    18148
    Inactive
    KETOPROFEN
    2005-02-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-010 - Rev 02
    Valid
    Ketoprofen
    2010-07-08
    Japanese DMF

    Found JDMF

    218MF10395
    Ketoprofen at S. S. 11 Padana Super...
    2006-03-20
    Written Confirmation

    Close WC

    Application Number
    18148
    R1-CEP 2002-010 - Rev 02
    218MF10395
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    KETOPROFEN
    Ketoprofen
    Ketoprofen at S. S. 11 Padana Super...
    Issue/Submission Date
    2005-02-21
    2010-07-08
    2006-03-20
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    • FDA
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-142 - Rev 03
    Valid
    Ambroxol hydrochloride
    2011-02-10
    Japanese DMF

    Found JDMF

    220MF10085
    Ambroxol hydrochloride at S. S. 11 ...
    2008-03-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-142 - Rev 03
    220MF10085
    Status
    Valid
     
    Filing Details
    Ambroxol hydrochloride
    Ambroxol hydrochloride at S. S. 11 ...
    Issue/Submission Date
    2011-02-10
    2008-03-18
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    • FDA
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    Crotamiton

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    USDMF

    Caution USDMF

    15285
    Inactive
    CROTAMITON
    2001-02-08
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-131 - Rev 03
    Withdrawn by Holder
    Crotamiton
    2012-05-11
    Japanese DMF

    Found JDMF

    221MF10127
    Crotamiton at S. S. 11 Padana Super...
    2009-06-23
    Written Confirmation

    Close WC

    Application Number
    15285
    R1-CEP 1999-131 - Rev 03
    221MF10127
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CROTAMITON
    Crotamiton
    Crotamiton at S. S. 11 Padana Super...
    Issue/Submission Date
    2001-02-08
    2012-05-11
    2009-06-23
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    • FDA
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    Sodium Picosulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-068 - Rev 00
    Valid
    Sodium picosulfate
    2009-11-04
    Japanese DMF

    Found JDMF

    220MF10132
    Picosulfate sodium hydrate at S. S....
    2008-05-20
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-068 - Rev 00
    220MF10132
    Status
    Valid
     
    Filing Details
    Sodium picosulfate
    Picosulfate sodium hydrate at S. S....
    Issue/Submission Date
    2009-11-04
    2008-05-20
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    • FDA
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10046
    Ambroxol hydrochloride at S. S. 11 ...
    2007-02-13
    Written Confirmation

    Close WC

    Application Number
    219MF10046
    Status
     
    Filing Details
    Ambroxol hydrochloride at S. S. 11 ...
    Issue/Submission Date
    2007-02-13
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    Bisacodyl

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-037 - Rev 00
    Valid
    Bisacodyl, Powder
    2010-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-037 - Rev 00
    Status
    Valid
     
    Filing Details
    Bisacodyl, Powder
    Issue/Submission Date
    2010-01-07
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    Bisacodyl

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-067 - Rev 00
    Valid
    Bisacodyl
    2010-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-067 - Rev 00
    Status
    Valid
     
    Filing Details
    Bisacodyl
    Issue/Submission Date
    2010-01-07
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    • FDA
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    Bromhexine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-025 - Rev 02
    Valid
    Bromhexine hydrochloride
    2015-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-025 - Rev 02
    Status
    Valid
     
    Filing Details
    Bromhexine hydrochloride
    Issue/Submission Date
    2015-12-14
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    • FDA
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    Meloxicam

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    USDMF

    Found USDMF

    13846
    Active
    MELOXICAM
    1998-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13846
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MELOXICAM
    Issue/Submission Date
    1998-10-29
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    Metaproterenol Hemisulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-217 - Rev 00
    Valid
    Orciprenaline sulfate
    2012-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-217 - Rev 00
    Status
    Valid
     
    Filing Details
    Orciprenaline sulfate
    Issue/Submission Date
    2012-03-07
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    • FDA
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    Chlorthalidone

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    USDMF

    Caution USDMF

    4601
    Inactive
    CHLORTHALIDONE U.S.P.
    1982-06-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4601
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORTHALIDONE U.S.P.
    Issue/Submission Date
    1982-06-23
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    • FDA
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    Methocarbamol

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    USDMF

    Caution USDMF

    14906
    Inactive
    METHOCARBAMOL
    2000-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14906
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METHOCARBAMOL
    Issue/Submission Date
    2000-05-31
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    • FDA
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    Ribavirin

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    USDMF

    Caution USDMF

    15756
    Inactive
    RIBAVIRIN
    2001-10-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15756
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RIBAVIRIN
    Issue/Submission Date
    2001-10-01
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    3878
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1980-06-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3878
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1980-06-18
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