APPLICATION
ANDA211674
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-16
LATEST ACTION
2023-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
APREMILASTDiscontinued
APREMILAST 30MG · TABLET · ORAL
APREMILASTDiscontinued
APREMILAST 10MG · TABLET · ORAL
APREMILASTDiscontinued
APREMILAST 20MG · TABLET · ORAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.