Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211733

ADVIL DUAL ACTION WITH ACETAMINOPHEN (ACETAMINOPHEN; IBUPROFEN)
250MG;125MG
Marketing Status: Over-the-counter
Active Ingredient: ACETAMINOPHEN; IBUPROFEN
Proprietary Name: ADVIL DUAL ACTION WITH ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG;125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211733
Product Number: 001
Approval Date: Feb 28, 2020
Applicant Holder Full Name: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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