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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021373

CHILDREN'S ADVIL COLD (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
100MG/5ML;15MG/5ML
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ADVIL COLD
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML;15MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021373
Product Number: 001
Approval Date: Apr 18, 2002
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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