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List of Drug Master Files (DMF) of Alpharma brand of zopiclone 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 Sanofi
France
RHONE POULENC RORER PHARMACEUTICALS INC 3316 ZOPICLONE (26,267 R.P.) 1978-08-30 Inactive II N/A
26/09/2024 Calyx Chemicals & Pharmaceuticals Limited
India
CALYX CHEMICALS AND PHARMACEUTICALS LTD 15518 ZOPICLONE E.P. 2001-06-22 Active II N/A