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

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01 DILUTED ISOSORBIDE MONONITRATE (DRUG SUBSTANCE, NON-STERILE) (1)

02 METFORMIN HYDROCHLORIDE (2)

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01 SHANDONG KEYUAN PHARMACEUTICAL CO LTD (3)

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01 China (3)

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01 Active (1)

02 Inactive (2)

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01 Complete (1)

02 Blank (2)

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SHANDONG KEYUAN PHARM...
Inactive
21809
N/A
2008-06-18
II
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SHANDONG KEYUAN PHARM...
Inactive
24604
N/A
2011-01-17
II
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SHANDONG KEYUAN PHARM...
Active
33876
Complete
2023-07-10
2023-07-05
2019-05-16
II
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