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

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    01 ACYCLOVIR SODIUM DRUG SUBSTANCE (1)

    02 AMIODARONE HYDROCHLORIDE USP (1)

    03 APREMILAST (1)

    04 ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE PELLETS CAPSULES (1)

    05 AZITHROMYCIN GRANULES FOR ORAL SUSPENSION (1)

    06 CRISABOROLE (1)

    07 DESLORATADINE (1)

    08 DICLOFENAC SODIUM EXTENDED RELEASE CAPSULES (1)

    09 DOBUTAMINE HYDROCHLORIDE USP (1)

    10 ESOMEPRAZOLE SODIUM (1)

    11 FELODIPINE EXTENDED RELEASE TABLETS (1)

    12 GADOBUTROL USP (1)

    13 GADOTERATE MEGLUMINE (1)

    14 GADOTERIDOL USP (1)

    15 GANCICLOVIR SODIUM (1)

    16 GLUCOSAMINE HYDROCHLORIDE PELLETS CAPSULES (1)

    17 GLYCOPYRROLATE (1)

    18 MAGNESIUM HYDROXIDE USP (1)

    19 MEMANTINE HYDROCHLORIDE USP (1)

    20 MEMANTINE HYDROCHLORIDE, USP (1)

    21 METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS (1)

    22 SODIUM NITROPRUSSIDE USP (1)

    23 TECOVIRIMAT MONOHYDRATE (1)

    24 THEOPHYLLINE EXTENDED RELEASE CAPSULES (1)

    25 TRIMEBUTINE MALEATE DRUG SUBSTANCE (2)

    26 TRIMEBUTINE MALEATE TABLETS (1)

    27 VORICONAZOLE USP (1)

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    02 HAINAN POLY PHARM CO LTD (6)

    03 HAINAN POLY PHARMACEUTICAL CO LTD (13)

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    ACYCLOVIR SODIUM DRUG SUBSTANCE

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    HAINAN POLY PHARM CO ...
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    35112
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    2020-10-06
    2020-08-26
    2020-08-31
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    AMIODARONE HYDROCHLORIDE USP

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    HAINAN POLY PHARM CO ...
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    36163
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    2021-10-20
    2021-09-07
    2021-09-07
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    APREMILAST

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    ANHUI POLY PHARM CO L...
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    38437
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    2023-10-30
    2023-09-25
    2023-08-15
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    ASPIRIN AND DIPYRIDAMOLE EXTENDED R...

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    HAINAN POLY PHARMACEU...
    Inactive
    23734
    N/A
    2010-04-14
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    AZITHROMYCIN GRANULES FOR ORAL SUSP...

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    HAINAN POLY PHARMACEU...
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    23486
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    2010-01-27
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    CRISABOROLE

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    ANHUI POLY PHARM CO L...
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    39148
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    2024-01-09
    2023-12-15
    2023-11-30
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    DESLORATADINE

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    HAINAN POLY PHARMACEU...
    Inactive
    23926
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    2010-06-25
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    DICLOFENAC SODIUM EXTENDED RELEASE ...

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    HAINAN POLY PHARMACEU...
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    23243
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    2009-11-02
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    DOBUTAMINE HYDROCHLORIDE USP

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    HAINAN POLY PHARM CO ...
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    35217
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    2020-11-06
    2020-09-24
    2020-09-27
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    ESOMEPRAZOLE SODIUM

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    HAINAN POLY PHARM CO ...
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    35059
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    2020-09-17
    2020-08-13
    2020-08-13
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