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

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01 AMIKACIN BASE (1)

02 AMIKACIN HYDROCHLORIDE, NON-STERILE BULK DRUG (1)

03 AMIKACIN SULFATE (1:2) USP (1)

04 Amikacin Sulfate (1:1.8) USP, Non-Sterile Bulk Drug Substance (1)

05 DAPTOMYCIN (1)

06 DAPTOMYCIN, NON-STERILE, BULK DRUG (1)

07 LOVASTATIN (2)

08 LOVASTATIN, USP (1)

09 MEVASTATIN (1)

10 MYCOPHENOLATE MOFETIL (1)

11 MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE (1)

12 MYCOPHENOLATE SODIUM (1)

13 MYCOPHENOLIC ACID (1)

14 SIROLIMUS (1)

15 TOBRAMYCIN FORM-1 USP (1)

16 TOBRAMYCIN USP (1)

17 VANCOMYCIN HYDROCHLORIDE (1)

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01 CHONGQING DAXIN PHARMACEUTICAL CO LTD (16)

02 PKUCARE CHONGQING DAXIN PHARMACEUTICAL CO LTD (2)

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01 China (18)

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01 Active (12)

02 Inactive (6)

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01 Complete (4)

02 Blank (14)

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PKUCARE CHONGQING DAX...
Inactive
13760
N/A
1998-09-01
II
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CHONGQING DAXIN PHARM...
Inactive
14007
N/A
1999-03-05
II
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PKUCARE CHONGQING DAX...
Inactive
21035
N/A
2007-11-09
II
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CHONGQING DAXIN PHARM...
Inactive
13788
N/A
1998-09-01
II
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CHONGQING DAXIN PHARM...
Active
35241
N/A
2020-09-23
II
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CHONGQING DAXIN PHARM...
Active
29760
Complete
2015-12-04
2015-09-30
2015-11-12
II
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CHONGQING DAXIN PHARM...
Active
20061
N/A
2006-12-19
II
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CHONGQING DAXIN PHARM...
Active
35431
N/A
2020-12-11
II
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CHONGQING DAXIN PHARM...
Inactive
12496
N/A
1997-05-08
II
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CHONGQING DAXIN PHARM...
Active
28531
N/A
2014-07-31
II
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