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List of Drug Master Files (DMF) of pentyl N-[1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-methyloxolan-2-yl]-5-fluoro-2-oxopyrimidin-4-yl]carbamate 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 22479 CAPECITABINE USP 2009-01-30 Active II N/A
26/09/2024 Aarti Pharmalabs
India
AARTI PHARMALABS LTD 22954 CAPECITABINE 2009-07-17 Active II N/A