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List of Drug Master Files (DMF) of 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, ethyl ester, (3R,4R,5S)-, phosphate 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 Cipla
India
CIPLA LTD 21557 OSELTAMIVIR PHOSPHATE USP 2008-05-29 Active II Complete 2021-11-19 2021-09-30
26/09/2024 Hetero Drugs
India
HETERO LABS LTD 30412 OSELTAMIVIR PHOSPHATE 2016-03-16 Active II Complete 2016-07-19 2016-05-03