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    01 4-Biphenylacetic Acid (1)

    02 Alimemazine (1)

    03 Alpha Hydroxymethionine Calcium (1)

    04 Alpha Lipoic Acid (1)

    05 Avibactam Sodium (1)

    06 Aztreonam (2)

    07 Butorphanol (1)

    08 Capecitabine (1)

    09 Carbenicillin (1)

    10 Cefathiamidine (1)

    11 Cefazolin Sodium (1)

    12 Cefditoren Pivoxil (1)

    13 Cefmetazole Sodium (1)

    14 Cefotiam (1)

    15 Cefsulodin (1)

    16 Ceftizoxime Sodium (1)

    17 Cinacalcet Hydrochloride (1)

    18 Clavulanic Acid (1)

    19 Clindamycin Phosphate (1)

    20 Dexmedetomidine Hydrochloride (1)

    21 Diazoxide (1)

    22 Elagolix Sodium (1)

    23 Empagliflozin (1)

    24 Esomeprazole Sodium (1)

    25 Febuxostat (1)

    26 Finerenone (1)

    27 Flomoxef Sodium (1)

    28 Fosphenytoin Sodium (1)

    29 Gemcitabine (1)

    30 Hydroxychloroquine Sulphate (1)

    31 Indobufen (1)

    32 Isavuconazonium Sulfate (1)

    33 L-Ornithine L-aspartate (1)

    34 Lercanidipine (1)

    35 Lifitegrast (1)

    36 Midazolam Hydrochloride (1)

    37 Mosapride Citrate (1)

    38 Moxalactam (1)

    39 Nicergoline (1)

    40 Ornidazole (1)

    41 Oxacillin Sodium (1)

    42 Oxiracetam (1)

    43 Palbociclib (1)

    44 Piribedil (1)

    45 Quetiapine Hemifumarate (1)

    46 Ranolazine (1)

    47 Rebamipide (1)

    48 Rocuronium Bromide (1)

    49 Tenofovir Disoproxil Fumarate (1)

    50 Ticarcillin (1)

    51 Tigecycline (1)

    52 Tolvaptan (1)

    53 Toremifene Citrate (1)

    54 Voriconazole (1)

    55 cefminox sodium (1)

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    01 Active (7)

    02 Inactive (1)

    03 Blank (48)

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    01 Valid (1)

    02 Blank (55)

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    01 225MF10098 (1)

    02 Blank (55)

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    01 Blank (56)

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    • FDA
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    Aztreonam

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    USDMF

    Found USDMF

    27508
    Active
    AZTREONAM USP
    2013-09-11
    CEP/COS

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    Japanese DMF

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    Application Number
    27508
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    AZTREONAM USP
    Issue/Submission Date
    2013-09-11
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    Cefsulodin

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    USDMF

    Found USDMF

    29233
    Active
    CEFSULODIN
    2015-04-02
    CEP/COS

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    Application Number
    29233
    Status
    Active
    Fees Unpaid
    N/A
     
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    CEFSULODIN
    Issue/Submission Date
    2015-04-02
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    36681
    Active
    DEXMEDETOMIDINE HYDROCHLORIDE
    2022-06-29
    CEP/COS

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    Application Number
    36681
    Status
    Active
    Fees Unpaid
    N/A
     
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    DEXMEDETOMIDINE HYDROCHLORIDE
    Issue/Submission Date
    2022-06-29
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    Diazoxide

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    USDMF

    Found USDMF

    32771
    Active
    DIAZOXIDE USP
    2018-05-07
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    Application Number
    32771
    Status
    Active
    Fees Unpaid
    Reviewed
     
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    DIAZOXIDE USP
    Issue/Submission Date
    2018-05-07
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    Fosphenytoin Sodium

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    USDMF

    Found USDMF

    32816
    Active
    FOSPHENYTOIN SODIUM USP
    2018-08-08
    CEP/COS

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    Application Number
    32816
    Status
    Active
    Fees Unpaid
    Reviewed
     
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    FOSPHENYTOIN SODIUM USP
    Issue/Submission Date
    2018-08-08
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    Gemcitabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-042 - Rev 01
    Valid
    Gemcitabine hydrochloride
    2015-10-16
    Japanese DMF

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    Application Number
    R1-CEP 2009-042 - Rev 01
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride
    Issue/Submission Date
    2015-10-16
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    Lifitegrast

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    USDMF

    Found USDMF

    38179
    Active
    LIFITEGRAST
    2023-04-20
    CEP/COS

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    Application Number
    38179
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LIFITEGRAST
    Issue/Submission Date
    2023-04-20
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    Tigecycline

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    USDMF

    Found USDMF

    27477
    Active
    TIGECYCLINE
    2013-08-19
    CEP/COS

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    Application Number
    27477
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    TIGECYCLINE
    Issue/Submission Date
    2013-08-19
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    Toremifene Citrate

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    225MF10098
    Toremifene citrate at No. 6, Gongsa...
    2013-05-09
    Written Confirmation

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    Application Number
    225MF10098
    Status
     
    Filing Details
    Toremifene citrate at No. 6, Gongsa...
    Issue/Submission Date
    2013-05-09
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    Aztreonam

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    USDMF

    Caution USDMF

    23971
    Inactive
    AZTREONAM USP (NON-STERILE BULK DRU...
    2010-07-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    23971
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AZTREONAM USP (NON-STERILE BULK DRU...
    Issue/Submission Date
    2010-07-06
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