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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019771

ADVIL COLD AND SINUS (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
200MG;30MG
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: ADVIL COLD AND SINUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019771
Product Number: 001
Approval Date: Sep 19, 1989
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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