Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021277

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (MOXIFLOXACIN HYDROCHLORIDE)
400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: MOXIFLOXACIN HYDROCHLORIDE
Proprietary Name: AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021277
Product Number: 001
Approval Date: Nov 30, 2001
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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