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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Astellas Pharma to the U.S. FDA. Original Data : FDA Website

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    (TIARAMIDE HCL) GENERAL PROCEDURES

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    FUJISAWA PHARMACEUTIC...
    Inactive
    3282
    N/A
    1978-09-11
    II
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    CEFAZOLIN

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    ASTELLAS PHARMA INC
    Inactive
    10156
    N/A
    1991-10-08
    II
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    CEFAZOLIN SODIUM (STERILE)

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    ASTELLAS PHARMA INC
    Inactive
    13797
    N/A
    1998-09-01
    II
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    CEFIXIME

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    ASTELLAS PHARMA INC
    Inactive
    9478
    N/A
    1991-12-31
    II
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    CEFOTETAN

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    ASTELLAS PHARMA INC
    Inactive
    5074
    N/A
    1983-09-06
    II
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    CEPHALOSPORIN (ORAL) (FK482 CEFDINI...

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    ASTELLAS PHARMA INC
    Inactive
    8489
    N/A
    1990-03-28
    II
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    CEPHALOSPRIN C FERMENTATION AND REC...

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    ASTELLAS PHARMA INC
    Inactive
    9982
    N/A
    1972-08-07
    II
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    FAMOTIDINE

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    ASTELLAS PHARMA INC
    Inactive
    5746
    N/A
    1985-03-20
    II
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    FAMOTIDINE

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    ASTELLAS IRELAND CO L...
    Active
    7356
    N/A
    1988-02-29
    II
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    FK-037 DRUG SUBSTANCE (INJECTABLE C...

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    FUJISAWA PHARMACEUTIC...
    Inactive
    9698
    N/A
    1992-05-27
    II
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    FK330 DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Inactive
    17337
    N/A
    2004-04-22
    II
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    FK463 DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Active
    12856
    N/A
    1998-02-11
    II
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    FK962

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    ASTELLAS PHARMA INC
    Inactive
    17168
    N/A
    2004-02-19
    II
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    FORMOTEROL FUMARATE

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    ASTELLAS PHARMA INC
    Inactive
    12380
    N/A
    1997-02-24
    II
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    NILVADIPINE

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    FUJISAWA PHARMACEUTIC...
    Inactive
    14287
    N/A
    1999-07-12
    II
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    NILVADIPINE (FK 235,FR 34235)

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    FUJISAWA PHARMACEUTIC...
    Inactive
    6052
    N/A
    1985-10-07
    II
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    RHIZOXIN

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    FUJISAWA PHARMACEUTIC...
    Inactive
    10769
    N/A
    1994-03-14
    II
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    STERILE CEFAZOLIN SODIUM

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    FUJISAWA PHARMACEUTIC...
    Inactive
    9480
    N/A
    1991-12-16
    II
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    TACROLIMUS (FK506) DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Active
    16833
    N/A
    2003-09-12
    II
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    TAMOXIFEN CITRATE

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    FUJISAWA DEUTSCHLAND ...
    Inactive
    5060
    N/A
    1983-06-13
    II
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    TAMSULOSIN HYDROCHLORIDE

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    ASTELLAS IRELAND CO L...
    Inactive
    13878
    N/A
    1998-12-03
    II
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    TAMSULOSIN HYDROCHLORIDE

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    ASTELLAS PHARMA INC
    Inactive
    11761
    N/A
    1995-12-01
    II
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    VANCOMYCIN HYDROCHLORIDE

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    FUJISAWA PHARMACEUTIC...
    Inactive
    13694
    N/A
    1998-09-01
    II
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    ZOTEPINE DRUG SUBSTANCE

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    FUJISAWA PHARMACEUTIC...
    Inactive
    10116
    N/A
    1993-03-03
    II
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    7 ACA-A48

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    ASTELLAS PHARMA INC
    Inactive
    9479
    N/A
    1991-12-16
    II
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    FACILITY IN TOYOMA, JAPAN

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    FUJISAWA PHARMACEUTIC...
    Inactive
    9629
    N/A
    1992-04-01
    II
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    FACILITY LOCATED IN NAGOYA, JAPAN

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    FUJISAWA PHARMACEUTIC...
    Inactive
    9456
    N/A
    1991-12-07
    II
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    FACILITY LOCATED IN OSAKA, JAPAN

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    FUJISAWA PHARMACEUTIC...
    Inactive
    9457
    N/A
    1991-12-10
    II
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    FK 788 DRUG SUBSTANCE

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    FUJISAWA PHARMACEUTIC...
    Inactive
    14899
    N/A
    2000-05-26
    II
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    FK 881 DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Inactive
    16667
    N/A
    2003-06-27
    II
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    FK 960

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    FUJISAWA PHARMACEUTIC...
    Inactive
    13011
    N/A
    1998-05-26
    II
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    FK-866 DRUG SUBSTANCE

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    ASTELLAS PHARMA GMBH
    Inactive
    14816
    N/A
    2000-04-04
    II
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    FK117

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    FUJISAWA PHARMACEUTIC...
    Inactive
    15093
    N/A
    2000-10-12
    II
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    FK1706

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    ASTELLAS PHARMA INC
    Inactive
    18219
    N/A
    2005-03-31
    II
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    FK317

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    FUJISAWA PHARMACEUTIC...
    Inactive
    12969
    N/A
    1998-05-04
    II
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    FK366 ALDOSE REDUCTASE INHIBITOR

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    FUJISAWA PHARMACEUTIC...
    Inactive
    8066
    N/A
    1989-05-16
    II
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    FK506 (FK900506) DOSAGE FORMS

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    FUJISAWA PHARMACEUTIC...
    Inactive
    7601
    N/A
    1988-07-29
    II
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    FK555 DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Inactive
    17681
    N/A
    2004-09-15
    II
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    FK778 DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Inactive
    15574
    N/A
    2001-08-06
    II
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    FK8453 DRUG SUBSTANCE

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    FUJISAWA PHARMACEUTIC...
    Inactive
    14537
    N/A
    1999-11-19
    II
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    FK973 DRUG SUBSTANCE AND DRUG PRODU...

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    FUJISAWA PHARMACEUTIC...
    Inactive
    7629
    N/A
    1988-08-12
    II
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    • FDA
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    OXY-COMPOUND AN INTERMEDIATE TO PUR...

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    ASTELLAS PHARMA INC
    Inactive
    10153
    N/A
    1991-05-08
    II
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    SYNTHESIS OF PYRROINITRIN

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    FUJISAWA PHARMACEUTIC...
    Inactive
    1054
    N/A
    1967-04-21
    II
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    YM087 DRUG SUBSTANCE

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    ASTELLAS PHARMA INC
    Inactive
    12854
    N/A
    1998-02-10
    II
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