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    01 Aciclovir (1)

    02 Atenolol (3)

    03 Budesonide (1)

    04 Candesartan Cilexetil (1)

    05 Chlorhexidine Gluconate (1)

    06 Exenatide Synthetic (1)

    07 Foscarnet Sodium (1)

    08 Goserelin Acetate (2)

    09 Halothane (1)

    10 Hydrochlorothiazide (1)

    11 Inebilizumab (3)

    12 Lisinopril (3)

    13 Metoprolol Succinate (1)

    14 Nitroglycerin (1)

    15 Omeprazole (1)

    16 Omeprazole Magnesium (2)

    17 Propofol (1)

    18 Salbutamol Sulphate (1)

    19 Sodium Hydroxide (1)

    20 Terbutaline Sulphate (1)

    21 Tocainide (1)

    22 Blank (21)

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    01 Active (8)

    02 Inactive (29)

    03 Blank (13)

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    01 Valid (1)

    02 Blank (49)

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    01 302MF40018 (1)

    02 303MF40003 (1)

    03 303MF40004 (1)

    04 303MF40041 (1)

    05 303MF40060 (1)

    06 303MF40061 (1)

    07 304MF40032 (1)

    08 304MF40033 (1)

    09 305MF40037 (1)

    10 305MF40038 (1)

    11 305MF40039 (1)

    12 305MF40040 (1)

    13 Blank (38)

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    02 Blank (49)

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    Omeprazole

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    USDMF

    Caution USDMF

    4863
    Inactive
    OMEPRAZOLE CAPSULES
    1983-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-125 - Rev 06
    Valid
    Omeprazole
    2020-10-23
    Japanese DMF

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    Written Confirmation

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    Application Number
    4863
    R1-CEP 2000-125 - Rev 06
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE CAPSULES
    Omeprazole
    Issue/Submission Date
    1983-03-31
    2020-10-23
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    Budesonide

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    USDMF

    Found USDMF

    33171
    Active
    BUDESONIDE
    2018-10-10
    CEP/COS

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    Application Number
    33171
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUDESONIDE
    Issue/Submission Date
    2018-10-10
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    Goserelin Acetate

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    USDMF

    Found USDMF

    31488
    Active
    GOSERELIN ACETATE
    2017-04-21
    CEP/COS

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    Japanese DMF

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    Application Number
    31488
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GOSERELIN ACETATE
    Issue/Submission Date
    2017-04-21
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    Goserelin Acetate

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    USDMF

    Found USDMF

    31489
    Active
    GOSERELIN ACETATE IMPLANT
    2017-04-21
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    31489
    Status
    Active
    Fees Paid
    N/A
     
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    GOSERELIN ACETATE IMPLANT
    Issue/Submission Date
    2017-04-21
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    Inebilizumab

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF40018
    Medium / Medium Additives-Inebilizu...
    2020-06-04
    Written Confirmation

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    Application Number
    302MF40018
    Status
     
    Filing Details
    Medium / Medium Additives-Inebilizu...
    Issue/Submission Date
    2020-06-04
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    Inebilizumab

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF40003
    Medium / Medium Additives-Inebilizu...
    2021-01-26
    Written Confirmation

    Close WC

    Application Number
    303MF40003
    Status
     
    Filing Details
    Medium / Medium Additives-Inebilizu...
    Issue/Submission Date
    2021-01-26
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    Inebilizumab

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF40004
    Medium / Medium Additives-Inebelizu...
    2021-01-26
    Written Confirmation

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    Application Number
    303MF40004
    Status
     
    Filing Details
    Medium / Medium Additives-Inebelizu...
    Issue/Submission Date
    2021-01-26
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    Metoprolol Succinate

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    USDMF

    Found USDMF

    31140
    Active
    METOPROLOL SUCCINATE EXTENDED RELEA...
    2016-12-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31140
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METOPROLOL SUCCINATE EXTENDED RELEA...
    Issue/Submission Date
    2016-12-05
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    Omeprazole Magnesium

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    USDMF

    Found USDMF

    12694
    Active
    PRILOSEC MUPS TABLETS (OMEPRAZOLE M...
    1997-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    12694
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PRILOSEC MUPS TABLETS (OMEPRAZOLE M...
    Issue/Submission Date
    1997-10-09
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    Omeprazole Magnesium

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    USDMF

    Found USDMF

    12726
    Active
    OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE
    1997-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12726
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE
    Issue/Submission Date
    1997-10-31
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