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

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01 ALBUTEROL USP (1)

02 BECLOMETHASONE DIPROPIONATE (1)

03 BIOPIK (1)

04 BUDESONIDE USP (1)

05 EPINEPHRINE USP (1)

06 FLUTICASONE PROPIONATE, USP (1)

07 FORMOTEROL FUMARATE USP (1)

08 HEPARIN SODIUM USP (1)

09 INSULIN ASPART USP (1)

10 IPRATROPIUM BROMIDE USP (1)

11 ISOPROTERENOL HYDROCHLORIDE USP (1)

12 LIRAGLUTIDE (1)

13 MEDROXYPROGESTERONE ACETATE, USP (1)

14 PHYTONADIONE USP (1)

15 PROTAMINE SULFATE USP (1)

16 RECOMBINANT HUMAN INSULIN (1)

17 SALMETEROL XINAFOATE, USP (1)

18 SEMI-PURIFIED HEPARIN SODIUM (1)

19 SODIUM NITRITE INJECTION USP, 30 MG / ML, 10 ML (1)

20 SODIUM NITROPRUSSIDE USP (1)

21 TERIPARATIDE USP (1)

22 VASOPRESSIN USP (1)

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01 AMPHASTAR FRANCE PHARMACEUTICALS SAS (1)

02 AMPHASTAR NANJING PHARMACEUTICALS INC (16)

03 AMPHASTAR NANJING PHARMACEUTICALS INC (ANP) AN AMPHASTAR CO (1)

04 INTERNATIONAL MEDICAL IMPLANT (1)

05 INTERNATIONAL MEDICATION SYSTEMS LTD (3)

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01 China (1)

02 U.S.A (20)

03 United Kingdom (1)

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01 Active (19)

02 Inactive (3)

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01 Complete (12)

02 Blank (10)

URL Supplier Web Content
AMPHASTAR NANJING PHA...
Inactive
31034
N/A
2016-12-01
II
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AMPHASTAR NANJING PHA...
Active
27837
Complete
2015-01-05
2014-03-14
2014-03-06
II
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AMPHASTAR NANJING PHA...
Active
33714
N/A
2019-08-22
II
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AMPHASTAR NANJING PHA...
Active
33036
N/A
2018-08-08
II
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AMPHASTAR NANJING PHA...
Active
29454
Complete
2015-10-02
2015-07-10
2015-06-29
II
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AMPHASTAR NANJING PHA...
Active
33913
N/A
2019-08-09
II
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INTERNATIONAL MEDICAT...
Active
26070
Complete
2013-07-30
2012-12-12
2012-06-15
II
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AMPHASTAR NANJING PHA...
Active
32700
N/A
2018-05-16
II
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AMPHASTAR NANJING PHA...
Active
31036
Complete
2023-03-16
2022-11-04
2017-11-28
II
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AMPHASTAR NANJING PHA...
Active
29876
Complete
2016-01-13
2015-11-16
2015-11-09
II
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