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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019024

PHYSIOLYTE IN PLASTIC CONTAINER (MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE)
30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML
Marketing Status: Prescription
Active Ingredient: MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
Proprietary Name: PHYSIOLYTE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: SOLUTION; IRRIGATION
Strength: 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019024
Product Number: 001
Approval Date: Jun 8, 1984
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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