← FDA DRUG APPROVALS

FDA ANDA · ANDA070736

IBUPROFEN

Sponsor: RISING

APPLICATION
ANDA070736
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-12
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 300MG · TABLET · ORAL
IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
IBUPROFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL

Approval history

2016-05-09Labeling · Supplement 20 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 18AP
1989-05-12Labeling · Supplement 16AP
1989-03-01Manufacturing (CMC) · Supplement 13AP
1989-01-19Labeling · Supplement 14AP
1988-07-13Labeling · Supplement 11AP
1988-06-29Manufacturing (CMC) · Supplement 10AP
1988-05-17Manufacturing (CMC) · Supplement 9AP
1988-04-13Labeling · Supplement 8AP
1988-04-06Manufacturing (CMC) · Supplement 5AP
1987-11-04Manufacturing (CMC) · Supplement 4AP
1987-07-16Manufacturing (CMC) · Supplement 2AP
1987-07-16Manufacturing (CMC) · Supplement 3AP
1987-05-07Manufacturing (CMC) · Supplement 1AP
1986-06-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →