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List of Drug Master Files (DMF) of NCGC00024414-05 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 Supriya Lifescience
India
SUPRIYA LIFESCIENCE LTD 35174 DIPHENHYDRAMINE HYDROCHLORIDE USP 2020-09-03 Active II Complete 2022-01-07 2021-06-16
26/09/2024 Beijing Taiyang Pharmaceutical Industry
China
BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTD 19737 DIPHENHYDRAMINE HYDROCHLORIDE 2006-09-06 Active II Complete 2014-08-04 2013-12-02