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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021076

ALEVE-D SINUS & COLD (NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE)
220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: ALEVE-D SINUS & COLD
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021076
Product Number: 001
Approval Date: Nov 29, 1999
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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