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ADVIL ALLERGY AND CONGESTION RELIEF

NDA · New Drug Application · Sponsor: HALEON US HOLDINGS · Approved 2011-12-21

Drug application

FDA Application #
NDA022113
Application type
New Drug Application
Brand name
ADVIL ALLERGY AND CONGESTION RELIEF
Generic name
CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE
Active ingredients
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Over-the-counter
Sponsor
HALEON US HOLDINGS
Manufacturer
Haleon US Holdings LLC
First approval
2011-12-21

Source

Authoritative
Drugs@FDA application overview
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