← FDA DRUG APPROVALS

FDA NDA · NDA021374

ADVIL COLD AND SINUS

ibuprofen, pseudoephedrine hydrochloride

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021374
TYPE
NDA
ORIGINAL APPROVAL
2002-05-30
LATEST ACTION
2021-11-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

ADVIL COLD AND SINUS · ReferenceOver-the-counter
IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · CAPSULE · ORAL

Approval history

2021-11-19Labeling · Supplement 14 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 11 · standard — Label ↗AP
2011-03-14Labeling · Supplement 9 · unknown — Letter ↗AP
2009-05-19Labeling · Supplement 8 · standard — Letter ↗AP
2008-06-23Labeling · Supplement 7 · standard — Letter ↗AP
2006-04-17Labeling · Supplement 4 · standard — Letter ↗AP
2005-12-07Labeling · Supplement 5 · standard — Letter ↗AP
2003-10-17Labeling · Supplement 1 · standard — Letter ↗AP
2002-05-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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