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List of Drug Master Files (DMF) of Eszopiclone 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 21976 ESZOPICLONE USP 2008-09-13 Active II N/A
26/09/2024 Glenmark Life Sciences
India
GLENMARK LIFE SCIENCES LTD 21853 ESZOPICLONE USP 2008-08-04 Active II N/A