← FDA DRUG APPROVALS

FDA NDA · NDA022565

ADVIL SINUS CONGESTION AND PAIN

ibuprofen, phenylephrine hydrochloride

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA022565
TYPE
NDA
ORIGINAL APPROVAL
2010-05-27
LATEST ACTION
2021-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ADVIL CONGESTION RELIEF · ReferenceOver-the-counter
IBUPROFEN 200MG, PHENYLEPHRINE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2021-11-19Labeling · Supplement 9 · standard — Letter ↗AP
2020-07-30Labeling · Supplement 6 · standard — Label ↗AP
2019-07-09Labeling · Supplement 5 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 3 · standard — Label ↗AP
2015-03-30Labeling · Supplement 2 · standard — Label ↗AP
2010-05-27Type 4 - New Combination · Original · standard — Summary 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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