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

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    01 BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE (1)

    02 BENZTROPINE MESYLATE USP (1)

    03 CYCLOPHOSPHAMIDE USP (1)

    04 CYCLOPHOSPHAMIDE USP (STERILE) (1)

    05 DS108 DRUG SUBSTANCE (1)

    06 DS121 DRUG SUBTANCE (1)

    07 DS166 DRUG SUBSTANCE (1)

    08 FOMEPIZOLE (1)

    09 FOSAPREPITANT DIMEGLUMINE (1)

    10 HYDRALAZINE HYDROCHLORIDE USP (1)

    11 HYDRALAZINE HYDROCHLORIDE USP (P) GRADE (1)

    12 IRON SUCROSE COMPLEX (1)

    13 MARAVIROC (1)

    14 MELPHALAN HYDROCHLORIDE (1)

    15 MIGLUSTAT (1)

    16 NICARDIPINE HYDROCHLORIDE USP (1)

    17 PENICILLAMINE USP (1)

    18 PHENOXYBENZAMINE HYDROCHLORIDE USP (1)

    19 PHYTONADIONE USP (PROCESS A) (1)

    20 REMIFENTANIL HYDROCHLORIDE (1)

    21 ROPIVACAINE (1)

    22 ROPIVACAINE HYDROCHLORIDE USP (1)

    23 SEVELAMER CARBONATE (1)

    24 SEVELAMER HYDROCHLORIDE (1)

    25 SODIUM 4-PHENYLBUTYRATE (1)

    26 SODIUM FERRIC GLUCONATE COMPLEX (1)

    27 SODIUM NITROPRUSSIDE USP (1)

    28 TAUROLIDINE (1)

    29 TRIENTINE HYDROCHLORIDE USP (1)

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    BENDAMUSTINE HYDROCHLORIDE MONOHYDR...

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    NAVINTA LLC
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    27272
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    2013-12-18
    2013-09-18
    2013-09-19
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    BENZTROPINE MESYLATE USP

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    NAVINTA LLC
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    32136
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    2018-12-29
    2018-10-11
    2018-02-09
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    CYCLOPHOSPHAMIDE USP

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    NAVINTA LLC
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    38232
    N/A
    2023-03-31
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    CYCLOPHOSPHAMIDE USP (STERILE)

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    NAVINTA LLC
    Active
    35975
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    2021-11-17
    2021-09-27
    2021-09-28
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    DS121 DRUG SUBTANCE

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    NAVINTA LLC
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    30492
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    2017-01-13
    2016-09-02
    2016-09-06
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    DS166 DRUG SUBSTANCE

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    NAVINTA LLC
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    36918
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    2022-03-25
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    FOMEPIZOLE

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    NAVINTA LLC
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    2006-08-10
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    FOSAPREPITANT DIMEGLUMINE

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    NAVINTA LLC
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    2018-11-07
    2018-09-24
    2018-09-27
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    HYDRALAZINE HYDROCHLORIDE USP

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    NAVINTA LLC
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    19904
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    2006-10-26
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    HYDRALAZINE HYDROCHLORIDE USP (P) G...

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    24321
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    2010-10-28
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