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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022565

ADVIL CONGESTION RELIEF (IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE)
200MG;10MG
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: ADVIL CONGESTION RELIEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022565
Product Number: 001
Approval Date: May 27, 2010
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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