← FDA DRUG APPROVALS

FDA NDA · NDA020812

INFANTS ADVIL

ibuprofen

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020812
TYPE
NDA
ORIGINAL APPROVAL
1998-01-30
LATEST ACTION
2017-07-06
ROUTE
ORAL
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Over-the-counter, Discontinued

Products

INFANT'S ADVIL · ReferenceOver-the-counter
IBUPROFEN 50MG/1.25ML · SUSPENSION/DROPS · ORAL
PEDIATRIC ADVIL · ReferenceDiscontinued
IBUPROFEN 100MG/2.5ML · SUSPENSION/DROPS · ORAL

Approval history

2017-07-06Labeling · Supplement 24 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 23 · standard — Label ↗AP
2015-02-26Manufacturing (CMC) · Supplement 22 · standardAP
2014-03-11Manufacturing (CMC) · Supplement 21 · standardAP
2013-12-06Manufacturing (CMC) · Supplement 20 · standardAP
2013-07-24Manufacturing (CMC) · Supplement 19 · standard — Letter ↗AP
2011-04-26Labeling · Supplement 17 · unknown — Letter ↗AP
2009-05-19Labeling · Supplement 15 · standard — Letter ↗AP
2008-06-11Labeling · Supplement 14 · standard — Letter ↗AP
2006-04-04Labeling · Supplement 12 · standard — Letter ↗AP
2004-09-10Labeling · Supplement 11 · standard — Letter ↗AP
2002-06-28Manufacturing (CMC) · Supplement 9 · standardAP
2001-08-02Manufacturing (CMC) · Supplement 8 · standardAP
2000-09-07Labeling · Supplement 7 · standard — Review ↗AP
2000-02-10Manufacturing (CMC) · Supplement 6 · standardAP
2000-01-12Efficacy · Supplement 3 · standard — Label ↗AP
1998-10-14Manufacturing (CMC) · Supplement 4 · standardAP
1998-06-19Manufacturing (CMC) · Supplement 1 · standardAP
1998-05-19Manufacturing (CMC) · Supplement 2 · standardAP
1998-01-30Type 3 - New Dosage Form · Original · standard — 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 →