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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021394

ADVIL PM (DIPHENHYDRAMINE CITRATE; IBUPROFEN)
38MG;200MG
Marketing Status: Over-the-counter
Active Ingredient: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Proprietary Name: ADVIL PM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 38MG;200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021394
Product Number: 001
Approval Date: Dec 21, 2005
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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