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

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    01 CARMUSTINE (BCNU) (1)

    02 CYCLOPHOSPHAMIDE MONOHYDRATE (1)

    03 DEXMETHYLPHENIDATE HCl API (1)

    04 LABETALOL HYDROCHLORIDE (1)

    05 LEVORPHANOL TARTRATE DRUG SUBSTANCE (1)

    06 METHYLPHENIDATE HCI (1)

    07 OSELTAMIVIR PHOSPHATE DRUG SUBSTANCE (1)

    08 REMIFENTANIL HYDROCHLORIDE (1)

    09 TAPENTADOL HCI (1)

    10 TEMOZOLOMIDE (1)

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    01 AMPAC FINE CHEMICALS LLC (10)

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    01 U.S.A (10)

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    CARMUSTINE (BCNU)

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    AMPAC FINE CHEMICALS ...
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    13169
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    2016-05-16
    2016-04-18
    1998-09-01
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    CYCLOPHOSPHAMIDE MONOHYDRATE

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    AMPAC FINE CHEMICALS ...
    Active
    32492
    N/A
    2018-02-09
    II
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    DEXMETHYLPHENIDATE HCl API

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    AMPAC FINE CHEMICALS ...
    Active
    29784
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    2017-11-07
    2017-10-10
    2015-10-07
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    LABETALOL HYDROCHLORIDE

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    AMPAC FINE CHEMICALS ...
    Active
    35233
    N/A
    2021-11-17
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    LEVORPHANOL TARTRATE DRUG SUBSTANCE

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    AMPAC FINE CHEMICALS ...
    Active
    34304
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    2023-05-17
    2023-04-03
    2020-01-17
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    METHYLPHENIDATE HCI

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    AMPAC FINE CHEMICALS ...
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    30116
    N/A
    2016-04-14
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    OSELTAMIVIR PHOSPHATE DRUG SUBSTANC...

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    AMPAC FINE CHEMICALS ...
    Active
    35234
    Complete
    2022-06-23
    2022-06-13
    2021-08-06
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    REMIFENTANIL HYDROCHLORIDE

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    AMPAC FINE CHEMICALS ...
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    34303
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    2021-04-14
    2021-02-17
    2020-11-18
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    TAPENTADOL HCI

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    AMPAC FINE CHEMICALS ...
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    28541
    N/A
    2014-09-25
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    TEMOZOLOMIDE

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    AMPAC FINE CHEMICALS ...
    Active
    28580
    Complete
    2019-06-12
    2019-04-30
    2014-09-25
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