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

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    01 Betahistine Dihydrochloride (1)

    02 Omeprazole (1)

    03 Oxymorphone Hydrochloride (1)

    04 Supidimide (1)

    05 Tapentadol (1)

    06 Tramadol Hydrochloride (2)

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    01 Active (1)

    02 Inactive (3)

    03 Blank (3)

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    01 Expired (2)

    02 Valid (3)

    03 Blank (2)

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    01 218MF10134 (1)

    02 Blank (6)

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    01 Blank (7)

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    Tramadol Hydrochloride

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    USDMF

    Caution USDMF

    9811
    Inactive
    TRAMADOL HYDROCHLORIDE
    1992-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-204 - Rev 01
    Valid
    Tramadol hydrochloride
    2011-05-03
    Japanese DMF

    Found JDMF

    218MF10134
    Tramadol hydrochloride at Tschachen...
    2006-01-30
    Written Confirmation

    Close WC

    Application Number
    9811
    R1-CEP 2002-204 - Rev 01
    218MF10134
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Tramadol hydrochloride
    Tramadol hydrochloride at Tschachen...
    Issue/Submission Date
    1992-08-05
    2011-05-03
    2006-01-30
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    17166
    Active
    TRAMADOL HYDROCHLORIDE
    2004-02-18
    CEP/COS

    Caution CEP/COS

    R0-CEP 2002-138 - Rev 02
    Expired
    Tramadol hydrochloride
    2004-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17166
    R0-CEP 2002-138 - Rev 02
    Status
    Active
    Fees Unpaid
    N/A
    Expired
     
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Tramadol hydrochloride
    Issue/Submission Date
    2004-02-18
    2004-11-12
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    Betahistine Dihydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-001 - Rev 01
    Valid
    Betahistine dihydrochloride
    2017-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-001 - Rev 01
    Status
    Valid
     
    Filing Details
    Betahistine dihydrochloride
    Issue/Submission Date
    2017-11-30
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    Tapentadol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-390 - Rev 00
    Valid
    Tapentadol hydrochloride
    2022-10-03
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2021-390 - Rev 00
    Status
    Valid
     
    Filing Details
    Tapentadol hydrochloride
    Issue/Submission Date
    2022-10-03
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    Omeprazole

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2002-144 - Rev 01
    Expired
    Omeprazole
    2005-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2002-144 - Rev 01
    Status
    Expired
     
    Filing Details
    Omeprazole
    Issue/Submission Date
    2005-02-08
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    Oxymorphone Hydrochloride

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    USDMF

    Caution USDMF

    23754
    Inactive
    EXTENDED-RELEASE OXYMORPHONE HYDROC...
    2010-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23754
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    EXTENDED-RELEASE OXYMORPHONE HYDROC...
    Issue/Submission Date
    2010-04-29
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    Supidimide

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    USDMF

    Caution USDMF

    3156
    Inactive
    SUPIDIMIDE (FACILITIES AND CONTROLS...
    1978-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3156
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    SUPIDIMIDE (FACILITIES AND CONTROLS...
    Issue/Submission Date
    1978-03-21
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