← FDA DRUG APPROVALS

FDA ANDA · ANDA078682

IBUPROFEN

Sponsor: BIONPHARMA

APPLICATION
ANDA078682
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-24
LATEST ACTION
2019-11-12
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

2019-11-12Manufacturing (CMC) · Supplement 20 · unknown — Review ↗AP
2019-02-21Labeling · Supplement 16 · standard — Review ↗AP
2019-02-21Labeling · Supplement 21 · standard — Review ↗AP
2013-07-31Labeling · Supplement 12 · standardAP
2013-03-12Labeling · Supplement 3AP
2012-04-27Manufacturing (CMC) · Supplement 7AP
2009-03-24Original — Review ↗AP
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 →