← FDA DRUG APPROVALS

FDA ANDA · ANDA077338

IBUPROFEN

Sponsor: P AND L DEV LLC

APPLICATION
ANDA077338
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-10
LATEST ACTION
2009-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

IBUPROFENOver-the-counter
IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT · CAPSULE · ORAL

Approval history

2009-07-10OriginalAP
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 →