Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 021587

CHILDREN'S ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
1MG/5ML;100MG/5ML;15MG/5ML
Marketing Status: Over-the-counter

Active Ingredient: CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ADVIL ALLERGY SINUS
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 1MG/5ML;100MG/5ML;15MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021587
Product Number: 001
Approval Date: Feb 24, 2004
Applicant Holder Full Name: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC
Marketing Status: Over-the-counter
Patent and Exclusivity Information