← FDA DRUG APPROVALS

FDA ANDA · ANDA070709

IBUPROFEN

Sponsor: SUPERPHARM

APPLICATION
ANDA070709
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-25
LATEST ACTION
1989-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL

Approval history

1989-05-26Labeling · Supplement 16AP
1989-02-01Labeling · Supplement 12AP
1988-06-14Labeling · Supplement 11AP
1988-04-08Labeling · Supplement 10AP
1987-04-15Labeling · Supplement 3AP
1986-04-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →