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List of Drug Master Files (DMF) of Prestwick3_000192 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 ANDRULIS PHARMACEUTICALS CORP
U.S.A
ANDRULIS PHARMACEUTICALS CORP 8263 THALIDOMIDE 1989-10-27 Inactive II N/A
26/09/2024 Hetero Drugs
India
HETERO LABS LTD 19745 THALIDOMIDE USP 2006-09-11 Active II Complete 2014-01-22 2013-12-06