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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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    Shandong Xinhua Pharmaceutical
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    No. 1 Lutai Avenue, Zibo High-tech Zone, Shandong Province
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    +86-533- 2196803
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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
    II
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    DIPYRONE (METAMIZOLE SODIUM MONOHYD...

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    SHANDONG XINHUA PHARM...
    Active
    31035
    N/A
    2016-10-19
    II
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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
    II
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    GLIMEPIRIDE

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    SHANDONG XINHUA PHARM...
    Active
    32319
    N/A
    2017-11-22
    II
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    HYDROCORTISONE

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    SHANDONG XINHUA PHARM...
    Inactive
    11606
    N/A
    1995-07-27
    II
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    HYDROCORTISONE

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    SHANDONG XINHUA PHARM...
    Active
    33073
    Complete
    2020-07-15
    2019-10-15
    2018-10-04
    II
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    HYDROCORTISONE ACETATE

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    SHANDONG XINHUA PHARM...
    Active
    37653
    N/A
    2022-12-06
    II
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    HYDROCORTISONE ACETATE

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    SHANDONG XINHUA PHARM...
    Inactive
    17263
    N/A
    2004-03-15
    II
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    IBUPROFEN

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    SHANDONG XINHUA PHARM...
    Active
    15511
    Complete
    2014-06-16
    2014-06-04
    2001-07-03
    II
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    IBUPROFEN BP 88/USP XXII

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    SHANDONG XIN HUA PHAR...
    Inactive
    11243
    N/A
    1994-11-29
    II
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    IBUPROFEN SODIUM

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    SHANDONG XINHUA PHARM...
    Active
    28403
    N/A
    2014-06-10
    II
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    IRISQUINONE

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    SHANDONG XINHUA PHARM...
    Inactive
    17302
    N/A
    2004-03-18
    II
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    LEVODOPA

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    SHANDONG XINHUA PHARM...
    Active
    22598
    Complete
    2018-10-02
    2018-09-28
    2009-03-05
    II
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    MELOXICAM

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    SHANDONG XINHUA PHARM...
    Active
    24476
    N/A
    2010-12-08
    II
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    OMEGA-3-ACID-ETHYL ESTERS

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    SHANDONG XINHUA PHARM...
    Active
    29184
    N/A
    2015-02-02
    II
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    PHENOBARBITAL

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    SHANDONG XINHUA PHARM...
    Active
    27827
    N/A
    2013-12-01
    II
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    PREDNISONE

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    SHANDONG XINHUA PHARM...
    Active
    35461
    N/A
    2020-12-22
    II
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    PREDNISONE ACETATE

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    SHANDONG XINHUA PHARM...
    Active
    34479
    N/A
    2020-02-18
    II
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    SEVELAMER CARBONATE

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    SHANDONG XINHUA PHARM...
    Active
    35326
    Complete
    2021-05-14
    2021-02-08
    2020-11-02
    II
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    THEOPHYLLINE

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    SHANDONG XINHUA PHARM...
    Active
    4633
    N/A
    1982-07-28
    II
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    TRIMETHOPRIM USP

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    SHANDONG XINHUA PHARM...
    Active
    13144
    Complete
    2015-06-10
    2015-05-27
    1998-08-18
    II
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    FACILITY AND PROCEDURES IN ZIBO, SH...

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    SHANDONG XIN HUA PHAR...
    Inactive
    10719
    N/A
    1994-01-20
    II
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