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

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    01 AMLODIPINE BESYLATE (1)

    02 ASPIRIN (1)

    03 ASPIRIN REFINED (1)

    04 ASPIRIN/STARCH/POVIDONE DC-90 (1)

    05 CAFFEINE ANHYDROUS (1)

    06 CALCIUM POLYCARBOPHIL (1)

    07 CARBIDOPA (1)

    08 DIPYRONE (METAMIZOLE SODIUM MONOHYDRATE) (1)

    09 ETHYL ICOSAPENTATE 70 (1)

    10 ETHYL ICOSAPENTATE 98 (1)

    11 FACILITY AND PROCEDURES IN ZIBO, SHANDONG, THE PEOPLE'S REPUBLIC OF CHINA. (1)

    12 GLIMEPIRIDE (1)

    13 HYDROCORTISONE (2)

    14 HYDROCORTISONE ACETATE (2)

    15 IBUPROFEN (1)

    16 IBUPROFEN BP 88/USP XXII (1)

    17 IBUPROFEN SODIUM (1)

    18 IRISQUINONE (1)

    19 LEVODOPA (1)

    20 MELOXICAM (1)

    21 OMEGA-3-ACID-ETHYL ESTERS (1)

    22 PHENOBARBITAL (1)

    23 PREDNISONE (1)

    24 PREDNISONE ACETATE (1)

    25 SEVELAMER CARBONATE (1)

    26 THEOPHYLLINE (1)

    27 TRIMETHOPRIM USP (1)

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    01 SHANDONG XIN HUA PHARMACEUTICAL FACTORY (2)

    02 SHANDONG XINHUA PHARMACEUTICAL CO LTD (27)

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    AMLODIPINE BESYLATE

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    SHANDONG XINHUA PHARM...
    Inactive
    26132
    N/A
    2012-05-25
    II
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    ASPIRIN

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    SHANDONG XINHUA PHARM...
    Active
    10730
    Complete
    2017-02-01
    2017-01-03
    1994-01-20
    II
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    ASPIRIN REFINED

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    SHANDONG XINHUA PHARM...
    Active
    26844
    N/A
    2013-01-18
    II
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    ASPIRIN/STARCH/POVIDONE DC-90

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    SHANDONG XINHUA PHARM...
    Active
    29793
    N/A
    2015-10-12
    II
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    CAFFEINE ANHYDROUS

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    SHANDONG XINHUA PHARM...
    Active
    13092
    Complete
    2013-06-25
    2014-02-28
    1998-07-10
    II
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    CALCIUM POLYCARBOPHIL

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    SHANDONG XINHUA PHARM...
    Active
    37983
    N/A
    2023-04-26
    II
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    CARBIDOPA

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    SHANDONG XINHUA PHARM...
    Active
    27430
    Complete
    2018-04-20
    2017-12-04
    2013-07-23
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    DIPYRONE (METAMIZOLE SODIUM MONOHYD...

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    SHANDONG XINHUA PHARM...
    Active
    31035
    N/A
    2016-10-19
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    ETHYL ICOSAPENTATE 70

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    SHANDONG XINHUA PHARM...
    Active
    35160
    N/A
    2020-09-08
    II
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    ETHYL ICOSAPENTATE 98

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    SHANDONG XINHUA PHARM...
    Active
    34361
    Complete
    2021-12-10
    2021-05-21
    2020-03-10
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