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    01 2-Nitro-4,5-Dihydro-1,3-Thiazole (1)

    02 Adenosine (1)

    03 Amrinone (1)

    04 Amtolmetin Guacil (1)

    05 Atenolol (1)

    06 Azacitidine (1)

    07 Azanidazole (1)

    08 Bendamustine Hydrochloride (1)

    09 Benzocaine (1)

    10 Bromfenac (1)

    11 Buspirone Hydrochloride (1)

    12 Busulfan (1)

    13 CAS 24219-97-4 (1)

    14 Capecitabine (1)

    15 Carbaspirin Calcium (1)

    16 Citicoline Sodium (1)

    17 Cytarabine (2)

    18 Desipramine Hydrochloride (1)

    19 Diacerein (2)

    20 Dihydralazine Sulfate (1)

    21 Disopyramide (1)

    22 Doxylamine Succinate (1)

    23 Erythromycin Ethyl Succinate (1)

    24 Erythromycin Stearate (1)

    25 Ethyl 4-Butylamino-Benzoate (1)

    26 Fludarabine Phosphate (1)

    27 Gemcitabine (1)

    28 Glycerylphosphorylcholine (1)

    29 Gold Sodium Thiomalate (1)

    30 Hydralazine Hydrochloride (2)

    31 Hydroxyurea (1)

    32 Imipramine Hydrochloride (1)

    33 Lithium Carbonate (1)

    34 Oxcarbazepine (1)

    35 Pentylenetetrazole (1)

    36 Pirenzepine (2)

    37 Propofol (1)

    38 Ribavirin (1)

    39 Sancycline (1)

    40 Sucralfate (1)

    41 Sucrose Octasulfate (1)

    42 Sulfapyridine (1)

    43 Sulfathiazole Sodium (1)

    44 Terazosin HCl (1)

    45 Tetracycline (1)

    46 Tetracycline Hydrochloride (1)

    47 Tolmetin (1)

    48 Triclocarban (1)

    49 Vidarabine (2)

    50 Blank (5)

    filter

    01 Active (15)

    02 Inactive (29)

    03 Blank (15)

    filter

    01 Expired (2)

    02 Valid (5)

    03 Withdrawn by Holder (1)

    04 Blank (51)

    filter

    01 218MF10132 (1)

    02 227MF10026 (1)

    03 Blank (57)

    filter

    01 Blank (59)

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    • FDA
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    Cytarabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25267
    Active
    CYTARABINE
    2011-09-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-048 - Rev 04
    Valid
    Cytarabine
    2020-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25267
    R1-CEP 2000-048 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CYTARABINE
    Cytarabine
    Issue/Submission Date
    2011-09-07
    2020-10-16
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    Diacerein

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23960
    Active
    DIACEREIN (PROCESS I)
    2010-07-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-247 - Rev 00
    Valid
    Diacerein
    2021-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23960
    R1-CEP 2014-247 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DIACEREIN (PROCESS I)
    Diacerein
    Issue/Submission Date
    2010-07-13
    2021-06-24
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    Hydroxyurea

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    USDMF

    Found USDMF

    12754
    Active
    HYDROXYUREA
    1997-11-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-120 - Rev 03
    Valid
    Hydroxycarbamide
    2020-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    12754
    R1-CEP 2003-120 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROXYUREA
    Hydroxycarbamide
    Issue/Submission Date
    1997-11-14
    2020-09-18
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    Diacerein

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23961
    Active
    DIACEREIN (PROCESS II)
    2010-07-13
    CEP/COS

    Caution CEP/COS

    R0-CEP 2014-248 - Rev 00
    Expired
    Diacerein
    2016-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23961
    R0-CEP 2014-248 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Expired
     
    Filing Details
    DIACEREIN (PROCESS II)
    Diacerein
    Issue/Submission Date
    2010-07-13
    2016-07-21
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    Fludarabine Phosphate

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    USDMF

    Caution USDMF

    17374
    Inactive
    FLUDARABINE PHOSPHATE
    2004-05-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-282 - Rev 00
    Valid
    Fludarabine phosphate
    2016-10-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17374
    R1-CEP 2009-282 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUDARABINE PHOSPHATE
    Fludarabine phosphate
    Issue/Submission Date
    2004-05-13
    2016-10-14
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    Hydralazine Hydrochloride

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    USDMF

    Found USDMF

    22169
    Active
    HYDRALAZINE HYDROCHLORIDE
    2008-10-31
    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-161 - Rev 01
    Expired
    Hydralazine hydrochloride
    2020-10-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22169
    R0-CEP 2015-161 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE
    Hydralazine hydrochloride
    Issue/Submission Date
    2008-10-31
    2020-10-29
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    Adenosine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22232
    Active
    ADENOSINE
    2008-11-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22232
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ADENOSINE
    Issue/Submission Date
    2008-11-25
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    Bromfenac

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    USDMF

    Found USDMF

    23704
    Active
    BROENAC SODIUM
    2010-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    23704
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BROENAC SODIUM
    Issue/Submission Date
    2010-04-12
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    Capecitabine

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    USDMF

    Found USDMF

    25266
    Active
    CAPECITABINE
    2011-09-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25266
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CAPECITABINE
    Issue/Submission Date
    2011-09-07
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    Cytarabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-289 - Rev 00
    Valid
    Cytarabine, Process 2
    2024-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-289 - Rev 00
    Status
    Valid
     
    Filing Details
    Cytarabine, Process 2
    Issue/Submission Date
    2024-02-06
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