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    4815 Emperor Blvd., Suite 300
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    Pyridostigmine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2003-117 - Rev 03
    Valid
    Pyridostigmine bromide
    2016-12-15
    Japanese DMF

    Found JDMF

    227MF10212
    Pyridostigmine bromide at St. -Pete...
    2015-08-18
    Written Confirmation

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    Application Number
    R1-CEP 2003-117 - Rev 03
    227MF10212
    Status
    Valid
     
    Filing Details
    Pyridostigmine bromide
    Pyridostigmine bromide at St. -Pete...
    Issue/Submission Date
    2016-12-15
    2015-08-18
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    Clodronic Acid Disodium Salt

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2011-060 - Rev 00
    Valid
    Clodronate disodium tetrahydrate
    2018-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2011-060 - Rev 00
    Status
    Valid
     
    Filing Details
    Clodronate disodium tetrahydrate
    Issue/Submission Date
    2018-06-13
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    Fostamatinib Disodium Hexahydrate

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    304MF10064
    Fostamatinib Disodium Hexahydrate a...
    2022-04-06
    Written Confirmation

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    Application Number
    304MF10064
    Status
     
    Filing Details
    Fostamatinib Disodium Hexahydrate a...
    Issue/Submission Date
    2022-04-06
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    Neostigmine Bromide

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    306MF10020
    Neostigmine Bromide at St. -Peter-S...
    2024-01-30
    Written Confirmation

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    Application Number
    306MF10020
    Status
     
    Filing Details
    Neostigmine Bromide at St. -Peter-S...
    Issue/Submission Date
    2024-01-30
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    Neostigmine Methylsulfate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2003-253 - Rev 02
    Valid
    Neostigmine metilsulfate
    2016-12-15
    Japanese DMF

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    Application Number
    R1-CEP 2003-253 - Rev 02
    Status
    Valid
     
    Filing Details
    Neostigmine metilsulfate
    Issue/Submission Date
    2016-12-15
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    Neostigmine Methylsulfate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2004-084 - Rev 02
    Valid
    Neostigmine bromide
    2016-12-15
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2004-084 - Rev 02
    Status
    Valid
     
    Filing Details
    Neostigmine bromide
    Issue/Submission Date
    2016-12-15
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    Patiromer Sorbitex Calcium

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10083
    Paciromer Sorbitex Calcium at St. -...
    2023-07-19
    Written Confirmation

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    Application Number
    305MF10083
    Status
     
    Filing Details
    Paciromer Sorbitex Calcium at St. -...
    Issue/Submission Date
    2023-07-19
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    Vitamin E

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10047
    Neosuchi gummy down methyl sulfate ...
    2010-02-09
    Written Confirmation

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    Application Number
    222MF10047
    Status
     
    Filing Details
    Neosuchi gummy down methyl sulfate ...
    Issue/Submission Date
    2010-02-09
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    • FDA
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    Latanoprost

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    USDMF

    Caution USDMF

    25924
    Inactive
    LATANOPROST
    2012-03-30
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    25924
    Status
    Inactive
    Fees Paid
    Reviewed
     
    Filing Details
    LATANOPROST
    Issue/Submission Date
    2012-03-30
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      Methyltyrosine

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      USDMF

      Caution USDMF

      16099
      Inactive
      METYROSINE USP
      2002-08-15
      CEP/COS

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      Japanese DMF

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      Written Confirmation

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      Application Number
      16099
      Status
      Inactive
      Fees Unpaid
      N/A
       
      Filing Details
      METYROSINE USP
      Issue/Submission Date
      2002-08-15
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        Travoprost

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        USDMF

        Caution USDMF

        28414
        Inactive
        TRAVOPROST, USP
        2014-10-07
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

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        Application Number
        28414
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        TRAVOPROST, USP
        Issue/Submission Date
        2014-10-07
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        MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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        USDMF

        Caution USDMF

        5252
        Inactive
        MANUFACTURING SITE, FACILITIES, PER...
        1984-01-24
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        5252
        Status
        Inactive
        Fees Paid
        N/A
         
        Filing Details
        MANUFACTURING SITE, FACILITIES, PER...
        Issue/Submission Date
        1984-01-24
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        MANUFACTURING SITE, FACILITIES AND PERSONNEL IN FORT ER...

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        USDMF

        Caution USDMF

        9584
        Inactive
        MANUFACTURING SITE, FACILITIES AND ...
        1992-03-12
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        9584
        Status
        Inactive
        Fees Paid
        N/A
         
        Filing Details
        MANUFACTURING SITE, FACILITIES AND ...
        Issue/Submission Date
        1992-03-12
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        MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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        USDMF

        Caution USDMF

        9689
        Inactive
        MANUFACTURING SITE, FACILITIES, PER...
        1992-05-11
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        9689
        Status
        Inactive
        Fees Paid
        N/A
         
        Filing Details
        MANUFACTURING SITE, FACILITIES, PER...
        Issue/Submission Date
        1992-05-11
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