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List of Drug Master Files (DMF) of Lincomycin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Guangzhou Pharmaceutical Holding Limited
China
GUANGZHOU PHARMACEUTICAL FACTORY 7002 LINCOMYCIN HCL 1987-06-01 Inactive II N/A
26/09/2024 HEC Pharm
China
HEC PHARM CO LTD 33500 LINCOMYCIN HYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE, BULK FORM 2019-01-24 Active II Complete 2019-05-10 2019-02-27