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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078446

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (POTASSIUM CHLORIDE; SODIUM CHLORIDE)
149MG/100ML;450MG/100ML
Marketing Status: Prescription
Active Ingredient: POTASSIUM CHLORIDE; SODIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 149MG/100ML;450MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078446
Product Number: 001
Approval Date: Sep 10, 2008
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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