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List of Drug Master Files (DMF) of MolPort-001-768-818 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 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 28405 LOMUSTINE USP 2014-07-11 Active II Complete 2023-02-27 2021-04-15
26/09/2024 STARKS ASSOC INC
U.S.A
STARKS ASSOC INC 2420 LOMUSTINE (CCNU) BULK 1975-03-11 Active II N/A