APPLICATION
ANDA076112
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 800MG · TABLET · ORAL
IBUPROFENPrescription
IBUPROFEN 400MG · TABLET · ORAL
IBUPROFENPrescription
IBUPROFEN 600MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 18 · standardAP
2021-04-28Labeling · Supplement 17 · standardAP
2019-07-22Labeling · Supplement 16 · standardAP
2016-05-09Labeling · Supplement 15 · standardAP
2008-12-11Labeling · Supplement 11AP
2006-03-31Labeling · Supplement 9AP
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.