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FDA NDA · NDA021587

CHILDREN'S ADVIL ALLERGY SINUS

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021587
TYPE
NDA
ORIGINAL APPROVAL
2004-02-24
LATEST ACTION
2017-03-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S ADVIL ALLERGY SINUS · ReferenceOver-the-counter
CHLORPHENIRAMINE MALEATE 1MG/5ML, IBUPROFEN 100MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 15MG/5ML · SUSPENSION · ORAL

Approval history

2017-03-24Labeling · Supplement 6 · standard — Label ↗AP
2006-04-04Labeling · Supplement 2 · standard — Letter ↗AP
2004-02-24Type 3 - New Dosage Form · Original · standard — Label ↗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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