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    Approved Drug Products of Astellas Pharma listed in the FDA Orange Book. Original Data : FDA Website

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    Astellas Pharma
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    2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411
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    +81-3-3244-3000
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    ADENOSINE

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    INJECTABLE; INJECT...
    3MG/ML **Federal R...
    1989-10-30
    19937
    ADENOCARD
    DISCN
    Yes
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    ADENOSINE

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    SOLUTION; INTRAVEN...
    60MG/20ML (3MG/ML)...
    1995-05-18
    20059
    ADENOSCAN
    DISCN
    Yes
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    ADENOSINE

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    SOLUTION; INTRAVEN...
    90MG/30ML (3MG/ML)...
    1995-05-18
    20059
    ADENOSCAN
    DISCN
    Yes
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    AMCINONIDE

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    CREAM; TOPICAL
    0.025% **Federal R...
    1982-01-01
    18116
    CYCLOCORT
    DISCN
    Yes
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    AMCINONIDE

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    CREAM; TOPICAL
    0.1% **Federal Reg...
    1982-01-01
    18116
    CYCLOCORT
    DISCN
    Yes
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    AMCINONIDE

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    OINTMENT; TOPICAL
    0.1% **Federal Reg...
    1982-01-01
    18498
    CYCLOCORT
    DISCN
    Yes
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    AMCINONIDE

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    LOTION; TOPICAL
    0.1%
    1988-06-13
    19729
    CYCLOCORT
    DISCN
    Yes
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    AMPHOTERICIN B

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    INJECTABLE, LIPOSO...
    50MG/VIAL
    1997-08-11
    50740
    AMBISOME
    RX
    Yes
    AB
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    AVACINCAPTAD PEGOL SODIUM

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    SOLUTION; INTRAVIT...
    EQ 2MG BASE/0.1ML ...
    2023-08-04
    217225
    IZERVAY
    RX
    Yes
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 500MG BASE/VIAL
    1983-09-15
    50560
    CEFIZOX
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 1GM BASE/VIAL
    1983-09-15
    50560
    CEFIZOX
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 2GM BASE/VIAL
    1983-09-15
    50560
    CEFIZOX
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 10GM BASE/VIAL
    1993-03-19
    50560
    CEFIZOX
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 20MG BASE/ML
    1984-10-03
    50589
    CEFIZOX IN DEXTROS...
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 40MG BASE/ML
    1984-10-03
    50589
    CEFIZOX IN DEXTROS...
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 20MG BASE/ML
    1995-04-13
    50589
    CEFIZOX IN PLASTIC...
    DISCN
    No
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    CEFTIZOXIME SODIUM

    PDF Supplier PDF
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    INJECTABLE; INJECT...
    EQ 40MG BASE/ML
    1995-04-13
    50589
    CEFIZOX IN PLASTIC...
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 1GM BASE/VIAL
    1994-03-31
    63294
    CEFIZOX
    DISCN
    No
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    CEFTIZOXIME SODIUM

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    INJECTABLE; INJECT...
    EQ 2GM BASE/VIAL
    1994-03-31
    63294
    CEFIZOX
    DISCN
    No
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    ENFORTUMAB VEDOTIN-EJFV

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    INJECTABLE; INJECT...
    20MG/VIAL
    761137
    PADCEV
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    ENFORTUMAB VEDOTIN-EJFV

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    INJECTABLE; INJECT...
    30MG/VIAL
    761137
    PADCEV
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    ENZALUTAMIDE

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    CAPSULE; ORAL
    40MG
    2012-08-31
    203415
    XTANDI
    RX
    Yes
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    ENZALUTAMIDE

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    TABLET; ORAL
    40MG
    2020-08-04
    213674
    XTANDI
    RX
    Yes
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    ENZALUTAMIDE

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    TABLET; ORAL
    80MG
    2020-08-04
    213674
    XTANDI
    RX
    Yes
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    ERLOTINIB HYDROCHLORIDE

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    TABLET; ORAL
    EQ 25MG BASE
    2004-11-18
    21743
    TARCEVA
    DISCN
    Yes
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    ERLOTINIB HYDROCHLORIDE

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    TABLET; ORAL
    EQ 100MG BASE
    2004-11-18
    21743
    TARCEVA
    DISCN
    Yes
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    ERLOTINIB HYDROCHLORIDE

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    TABLET; ORAL
    EQ 150MG BASE
    2004-11-18
    21743
    TARCEVA
    DISCN
    Yes
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    FEZOLINETANT

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    TABLET; ORAL
    45MG
    2023-05-12
    216578
    VEOZAH
    RX
    Yes
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    GILTERITINIB FUMARATE

    PDF Supplier PDF
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    TABLET; ORAL
    EQ 40MG BASE
    2018-11-28
    211349
    XOSPATA
    RX
    Yes
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    HYDROCORTISONE BUTYRATE

    PDF Supplier PDF
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    CREAM; TOPICAL
    0.1%
    1983-01-07
    18795
    LOCOID
    DISCN
    No
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    HYDROCORTISONE BUTYRATE

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    OINTMENT; TOPICAL
    0.1%
    1984-07-03
    19106
    LOCOID
    DISCN
    No
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    HYDROCORTISONE BUTYRATE

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    SOLUTION; TOPICAL
    0.1%
    1988-09-15
    19819
    LOCOID
    DISCN
    No
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    ISAVUCONAZONIUM SULFATE

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    CAPSULE; ORAL
    186MG
    2015-03-06
    207500
    CRESEMBA
    RX
    Yes
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    ISAVUCONAZONIUM SULFATE

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    CAPSULE; ORAL
    74.5MG
    2022-11-22
    207500
    CRESEMBA
    RX
    Yes
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    ISAVUCONAZONIUM SULFATE

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    POWDER; INTRAVENOU...
    372MG
    2015-03-06
    207501
    CRESEMBA
    RX
    Yes
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    MICAFUNGIN SODIUM

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    INJECTABLE; INTRAV...
    EQ 50MG BASE/VIAL
    2005-03-16
    21506
    MYCAMINE
    RX
    Yes
    AP
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    MICAFUNGIN SODIUM

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    INJECTABLE; INTRAV...
    EQ 100MG BASE/VIAL
    2006-06-27
    21506
    MYCAMINE
    RX
    Yes
    AP
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    MICAFUNGIN SODIUM

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    INJECTABLE; INJEC...
    50MG
    21754
    MYCAMINE
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    REGADENOSON

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    SOLUTION; INTRAVEN...
    0.4MG/5ML (0.08MG/...
    2008-04-10
    22161
    LEXISCAN
    RX
    Yes
    AP
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    SOLIFENACIN SUCCINATE

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    TABLET; ORAL
    5MG
    2004-11-19
    21518
    VESICARE
    RX
    Yes
    AB
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    SOLIFENACIN SUCCINATE

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    TABLET; ORAL
    10MG
    2004-11-19
    21518
    VESICARE
    RX
    Yes
    AB
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    SOLIFENACIN SUCCINATE

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    SUSPENSION; ORAL
    1MG/ML
    2020-05-26
    209529
    VESICARE LS
    RX
    Yes
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    TACROLIMUS

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    CAPSULE; ORAL
    EQ 1MG BASE
    1994-04-08
    50708
    PROGRAF
    RX
    Yes
    AB
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    TACROLIMUS

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    CAPSULE; ORAL
    EQ 5MG BASE
    1994-04-08
    50708
    PROGRAF
    RX
    Yes
    AB
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    TACROLIMUS

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    CAPSULE; ORAL
    EQ 0.5MG BASE
    1998-08-24
    50708
    PROGRAF
    RX
    Yes
    AB
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    TACROLIMUS

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    INJECTABLE; INJECT...
    EQ 5MG BASE/ML
    1994-04-08
    50709
    PROGRAF
    RX
    Yes
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    TACROLIMUS

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    CAPSULE, EXTENDED ...
    EQ 0.5MG BASE
    2013-07-19
    204096
    ASTAGRAF XL
    RX
    Yes
    AB
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    TACROLIMUS

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    CAPSULE, EXTENDED ...
    EQ 1MG BASE
    2013-07-19
    204096
    ASTAGRAF XL
    RX
    Yes
    AB
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    TACROLIMUS

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    CAPSULE, EXTENDED ...
    EQ 5MG BASE
    2013-07-19
    204096
    ASTAGRAF XL
    RX
    Yes
    AB
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    TACROLIMUS

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    FOR SUSPENSION; OR...
    EQ 0.2MG BASE/PACK...
    2018-05-24
    210115
    PROGRAF
    RX
    Yes
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