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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205352

ALEVE PM (DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM)
25MG;220MG
Marketing Status: Over-the-counter
Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Proprietary Name: ALEVE PM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;220MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205352
Product Number: 001
Approval Date: Jan 17, 2014
Applicant Holder Full Name: BAYER HEALTHCARE CONSUMER CARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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