← FDA DRUG APPROVALS

FDA NDA · NDA022113

ADVIL ALLERGY AND CONGESTION RELIEF

chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA022113
TYPE
NDA
ORIGINAL APPROVAL
2011-12-21
LATEST ACTION
2021-11-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ADVIL ALLERGY AND CONGESTION RELIEF · ReferenceOver-the-counter
CHLORPHENIRAMINE MALEATE 4MG, IBUPROFEN 200MG, PHENYLEPHRINE HYDROCHLORIDE 10MG · TABLET · ORAL
ADVIL MULTI-SYMPTOM COLD & FLU · ReferenceOver-the-counter
CHLORPHENIRAMINE MALEATE 4MG, IBUPROFEN 200MG, PHENYLEPHRINE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2021-11-23Labeling · Supplement 11 · standard — Letter ↗AP
2019-09-06Labeling · Supplement 8 · standard — Label ↗AP
2019-07-09Labeling · Supplement 7 · standard — Letter ↗AP
2019-01-25Labeling · Supplement 5 · standard — Label ↗AP
2018-02-26Labeling · Supplement 3 · standard — Letter ↗AP
2018-02-26Labeling · Supplement 4 · standard — Letter ↗AP
2017-04-28Efficacy · Supplement 1 · standard — Label ↗AP
2017-03-24Labeling · Supplement 2 · standardAP
2011-12-21Type 4 - New Combination · 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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