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

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01 5-ISOTHIOCYANATO-3-(TRIFLUOROMETHYL)PICOLINONITRILE (1)

02 BUPROPION HYDROCHLORIDE (1)

03 CIPROFLOXACIN HYDROCHLORIDE (1)

04 EMPAGLIFLOZIN (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

05 LEVOFLOXACIN (1)

06 SPIRONOLACTONE (1)

07 ZIDOVUDINE (NON-STERILE, BULK FORM) (1)

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01 ZHEJIANG LANGHUA PHARMACEUTICAL CO LTD (5)

02 ZHEJIANG XINHUA PHARMACEUTICAL CO LTD (2)

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01 China (7)

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01 Active (5)

02 Inactive (2)

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01 Complete (2)

02 Blank (5)

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ZHEJIANG XINHUA PHARM...
Inactive
20085
N/A
2006-12-21
II
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ZHEJIANG XINHUA PHARM...
Inactive
19876
N/A
2006-10-16
II
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ZHEJIANG LANGHUA PHAR...
Active
36541
N/A
2021-12-02
II
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ZHEJIANG LANGHUA PHAR...
Active
26712
Complete
2015-08-05
2014-11-13
2012-12-06
II
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ZHEJIANG LANGHUA PHAR...
Active
26881
Complete
2016-06-27
2015-08-12
2013-02-04
II
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ZHEJIANG LANGHUA PHAR...
Active
26695
N/A
2012-10-19
II
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5-ISOTHIOCYANATO-3-(TRIFLUOROMETHYL...

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ZHEJIANG LANGHUA PHAR...
Active
34503
N/A
2020-01-15
II
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