← FDA DRUG APPROVALS

FDA ANDA · ANDA070437

IBUPROFEN

Sponsor: WATSON LABS

APPLICATION
ANDA070437
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-21
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL

Approval history

2016-05-09Labeling · Supplement 23 · standardAP
2016-05-06Labeling · Supplement 24 · standardAP
1992-01-30Manufacturing (CMC) · Supplement 10AP
1992-01-30Manufacturing (CMC) · Supplement 9AP
1991-08-09Labeling · Supplement 19AP
1991-08-07Manufacturing (CMC) · Supplement 15AP
1991-05-22Labeling · Supplement 18AP
1990-11-19Manufacturing (CMC) · Supplement 16AP
1990-06-29Manufacturing (CMC) · Supplement 13AP
1989-07-12Labeling · Supplement 14AP
1989-03-24Labeling · Supplement 12AP
1988-07-08Labeling · Supplement 8AP
1988-04-04Labeling · Supplement 7AP
1987-01-30Manufacturing (CMC) · Supplement 5AP
1986-10-28Manufacturing (CMC) · Supplement 3AP
1986-04-30Manufacturing (CMC) · Supplement 2AP
1986-03-29Manufacturing (CMC) · Supplement 1AP
1985-08-21OriginalAP
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 →