Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021374

ADVIL COLD AND SINUS (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: ADVIL COLD AND SINUS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021374
Product Number: 001
Approval Date: May 30, 2002
Applicant Holder Full Name: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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