← DrugApprovals
HomeDrug Approvals

SOTRET (ISOTRETINOIN) — FDA Approval ANDA076503 (SUN PHARM INDS LTD)

SOTRET (ISOTRETINOIN) — FDA Approval ANDA076503 (SUN PHARM INDS LTD) is one of 9,000 drug approvals in the DrugApprovals dataset. Key details — Brand name: SOTRET; Active ingredients: ISOTRETINOIN; Application number: ANDA076503.

Brand nameSOTRET
Active ingredientsISOTRETINOIN
Application numberANDA076503
SponsorSUN PHARM INDS LTD
Dosage formCAPSULE
RouteORAL
Marketing statusDiscontinued
Products in application1
First approval date20030620
SourceopenFDA Drugs@FDA

🔍 Search all drug approvals →