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List of Drug Master Files (DMF) of Prestwick2_000921 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 187Xls download

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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 14036 NIZATIDINE USP 1999-03-16 Active II Complete 2013-09-04 2013-08-23
26/09/2024 Eli Lilly
U.S.A
ELI LILLY AND CO 6034 BULK PRODUCTION OF NIZATIDINE 1985-09-23 Inactive II N/A