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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211221

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% (DEXTROSE; SODIUM CHLORIDE)
5GM/100ML;225MG/100ML
Marketing Status: Prescription
Active Ingredient: DEXTROSE; SODIUM CHLORIDE
Proprietary Name: DEXTROSE 5% AND SODIUM CHLORIDE 0.225%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML;225MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A211221
Product Number: 001
Approval Date: Sep 15, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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