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List of Drug Master Files (DMF) of Prestwick3_001037 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 F. Hoffmann-La Roche
Switzerland
HOFFMANN LA ROCHE INC 8637 HIVID DIDEOXYCYTIDINE SYRUP 1990-07-11 Inactive II N/A
26/09/2024 Gilead Sciences
U.S.A
RAYLO CHEMICALS 6805 2',3'-DIDEOXYCYTIDINE 1987-01-28 Inactive II N/A