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FDA NDA · NDA021373

CHILDREN'S ADVIL COLD

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021373
TYPE
NDA
ORIGINAL APPROVAL
2002-04-18
LATEST ACTION
2017-03-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S ADVIL COLDOver-the-counter
IBUPROFEN 100MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 15MG/5ML · SUSPENSION · ORAL

Approval history

2017-03-24Labeling · Supplement 13 · standard — Label ↗AP
2012-12-07Manufacturing (CMC) · Supplement 12 · standardAP
2010-08-24Labeling · Supplement 11 · unknown — Letter ↗AP
2009-05-19Labeling · Supplement 9 · standard — Letter ↗AP
2008-12-03Labeling · Supplement 8 · standard — Letter ↗AP
2006-04-04Labeling · Supplement 5 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 3 · standard — Letter ↗AP
2003-03-25Labeling · Supplement 1 · standard — Letter ↗AP
2002-04-18Type 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.

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