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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019696

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER (MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE)
30MG/100ML;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML
Marketing Status: Prescription
Active Ingredient: MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Proprietary Name: ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/100ML;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019696
Product Number: 001
Approval Date: Sep 29, 1989
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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