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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Zhejiang Neo-dankong Pharm. Co.,ltd. to the U.S. FDA. Original Data : FDA Website

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01 ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE) (1)

02 ATORVASTATIN ATV44 (L1) (1)

03 ATORVASTATIN CALCIUM, NON-STERILE BULK DRUG SUBSTANCES (1)

04 ATORVASTATIN SODIUM NON-STERILE BULK DRUG SUBSTANCE (1)

05 ESOMEPRAZOLE SODIUM (NON-STERILE BULK DRUG SUBSTANCE) (1)

06 LINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE (1)

07 METHOHEXITAL, NON-STERILE, BULK DRUG (1)

08 ROSUVASTATIN CALCIUM INTERMEDIATE (R1.5) (1)

09 ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3) (1)

10 ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES (1)

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01 ZHEJIANG LEPU PHARMACEUTICAL CO LTD (6)

02 ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD (4)

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01 China (10)

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01 Active (8)

02 Inactive (2)

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01 Complete (3)

02 Blank (7)

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ZHEJIANG NEO DANKONG ...
Inactive
18831
N/A
2005-09-22
II
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ZHEJIANG LEPU PHARMAC...
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18835
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2005-10-04
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ZHEJIANG LEPU PHARMAC...
Active
26022
Complete
2013-11-19
2013-08-02
2012-04-28
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ZHEJIANG NEO DANKONG ...
Active
20535
N/A
2007-05-06
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ZHEJIANG LEPU PHARMAC...
Active
29082
Complete
2015-08-22
2015-03-11
2015-02-05
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ZHEJIANG LEPU PHARMAC...
Active
26962
N/A
2013-03-03
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ZHEJIANG NEO DANKONG ...
Inactive
17700
N/A
2004-09-23
II
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ZHEJIANG LEPU PHARMAC...
Active
20751
N/A
2007-07-27
II
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ZHEJIANG NEO DANKONG ...
Active
20677
N/A
2007-07-02
II
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ZHEJIANG LEPU PHARMAC...
Active
25781
Complete
2014-08-21
2013-12-17
2012-02-10
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