APPLICATION
ANDA074931
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-20
LATEST ACTION
2000-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2000-07-24Labeling · Supplement 5AP
2000-07-24Manufacturing (CMC) · Supplement 9AP
2000-05-03Manufacturing (CMC) · Supplement 6AP
2000-05-03Manufacturing (CMC) · Supplement 7AP
1999-08-16Manufacturing (CMC) · Supplement 1AP
1999-08-16Manufacturing (CMC) · Supplement 2AP
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.