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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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    01 (TIARAMIDE HCL) GENERAL PROCEDURES (1)

    02 7 ACA-A48 (1)

    03 CEFAZOLIN (1)

    04 CEFAZOLIN SODIUM (STERILE) (1)

    05 CEFIXIME (1)

    06 CEFOTETAN (1)

    07 CEPHALOSPORIN (ORAL) (FK482 CEFDINIR, CI-983) (1)

    08 CEPHALOSPRIN C FERMENTATION AND RECOVERY IN OSAKA, JAPAN. (1)

    09 FACILITY IN TOYOMA, JAPAN (1)

    10 FACILITY LOCATED IN NAGOYA, JAPAN (1)

    11 FACILITY LOCATED IN OSAKA, JAPAN (1)

    12 FAMOTIDINE (2)

    13 FK 788 DRUG SUBSTANCE (1)

    14 FK 881 DRUG SUBSTANCE (1)

    15 FK 960 (1)

    16 FK-037 DRUG SUBSTANCE (INJECTABLE CEPHALOSPORIN) (1)

    17 FK-866 DRUG SUBSTANCE (1)

    18 FK117 (1)

    19 FK1706 (1)

    20 FK317 (1)

    21 FK330 DRUG SUBSTANCE (1)

    22 FK366 ALDOSE REDUCTASE INHIBITOR (1)

    23 FK463 DRUG SUBSTANCE (1)

    24 FK506 (FK900506) DOSAGE FORMS (1)

    25 FK555 DRUG SUBSTANCE (1)

    26 FK778 DRUG SUBSTANCE (1)

    27 FK8453 DRUG SUBSTANCE (1)

    28 FK962 (1)

    29 FK973 DRUG SUBSTANCE AND DRUG PRODUCT IN AICHI & OSAKA, JAPAN (1)

    30 FORMOTEROL FUMARATE (1)

    31 NILVADIPINE (1)

    32 NILVADIPINE (FK 235,FR 34235) (1)

    33 OXY-COMPOUND AN INTERMEDIATE TO PURIFIED CEFTIZOXIME (1)

    34 RHIZOXIN (1)

    35 STERILE CEFAZOLIN SODIUM (1)

    36 SYNTHESIS OF PYRROINITRIN (1)

    37 TACROLIMUS (FK506) DRUG SUBSTANCE (1)

    38 TAMOXIFEN CITRATE (1)

    39 TAMSULOSIN HYDROCHLORIDE (2)

    40 VANCOMYCIN HYDROCHLORIDE (1)

    41 YM087 DRUG SUBSTANCE (1)

    42 ZOTEPINE DRUG SUBSTANCE (1)

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    01 ASTELLAS IRELAND CO LTD (2)

    02 ASTELLAS PHARMA GMBH (1)

    03 ASTELLAS PHARMA INC (20)

    04 FUJISAWA DEUTSCHLAND GMBH (1)

    05 FUJISAWA PHARMACEUTICAL CO (1)

    06 FUJISAWA PHARMACEUTICAL CO LTD (19)

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    01 Japan (44)

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    01 Active (3)

    02 Inactive (41)

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    01 Blank (44)

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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...
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    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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