← FDA DRUG APPROVALS

FDA ANDA · ANDA070733

IBUPROFEN

Sponsor: P AND L DEV LLC

APPLICATION
ANDA070733
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-19
LATEST ACTION
2000-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2000-01-28Manufacturing (CMC) · Supplement 13AP
1989-04-26Manufacturing (CMC) · Supplement 11AP
1988-06-29Manufacturing (CMC) · Supplement 9AP
1988-04-06Manufacturing (CMC) · Supplement 6AP
1988-04-06Labeling · Supplement 7AP
1987-11-03Manufacturing (CMC) · Supplement 5AP
1987-05-07Manufacturing (CMC) · Supplement 4AP
1987-05-07Manufacturing (CMC) · Supplement 2AP
1987-05-07Manufacturing (CMC) · Supplement 3AP
1987-05-07Manufacturing (CMC) · Supplement 1AP
1986-09-19OriginalAP
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 →