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

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    01 AMG 157 (TEZEPELUMAB) PHASE 3 CMC AMENDMENT (DRUG SUBSTANCE AND DRUG PRODUCT) (1)

    02 AMG 191 CELL LINE DEVELOPMENT (1)

    03 AMG 191 DRUG PRODUCT (1)

    04 AMG 191 DRUG SUBSTANCE (1)

    05 AMG 282 DRUG SUBSTANCE (1)

    06 BULK PURIFIED MURINE MONOCLONAL ANTIBODY (ABX-CBL) TO BLAST CELLS (1)

    07 HUMAN MONOCLONAL ANTIBODY (ABX-EGF) TO EPIDERMAL GROWTH FACTOR RECEPTOR (1)

    08 HUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15 (1)

    09 INTRAVENOUS SOLUTION STABILIZER (IVSS) (1)

    10 NON-STERILE SULBACTAM SODIUM (1)

    11 STERILE MIXTURE OF AMPICILLIN SODIUM AND SULBACTAM SODIUM (2:1) (1)

    12 STERILE SULBACTAM SODIUM (1)

    13 SULBACTAM SODIUM (NON-STERILE) (2)

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    01 ABGENIX INC (2)

    02 AMGEN INC (7)

    03 MASTAFA NEVZAT ILAC SANAYII (1)

    04 MUSTAFA NEVZAT ILAC SAN AS (1)

    05 MUSTAFA NEVZAT ILAC SANAYII AS (3)

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    01 Switzerland (2)

    02 Turkey (5)

    03 U.S.A (7)

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    01 Active (6)

    02 Inactive (8)

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    01 Blank (14)

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    STERILE MIXTURE OF AMPICILLIN SODIU...

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    MUSTAFA NEVZAT ILAC S...
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    24360
    N/A
    2010-11-12
    II
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    STERILE SULBACTAM SODIUM

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    MUSTAFA NEVZAT ILAC S...
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    22261
    N/A
    2008-12-04
    II
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    SULBACTAM SODIUM (NON-STERILE)

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    MASTAFA NEVZAT ILAC S...
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    16587
    N/A
    2003-05-14
    II
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    SULBACTAM SODIUM (NON-STERILE)

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    MUSTAFA NEVZAT ILAC S...
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    17560
    N/A
    2004-05-26
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    AMG 157 (TEZEPELUMAB) PHASE 3 CMC A...

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    AMGEN INC
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    31671
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    2017-08-21
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    AMG 191 CELL LINE DEVELOPMENT

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    AMGEN INC
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    29877
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    2015-11-06
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    AMG 191 DRUG PRODUCT

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    AMGEN INC
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    2015-11-06
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    AMG 191 DRUG SUBSTANCE

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    AMGEN INC
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    2015-11-06
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    AMG 282 DRUG SUBSTANCE

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    AMGEN INC
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    30198
    N/A
    2016-02-22
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    BULK PURIFIED MURINE MONOCLONAL ANT...

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    ABGENIX INC
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    18660
    N/A
    1999-06-04
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