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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204559

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE)
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Marketing Status: Prescription
Active Ingredient: POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Proprietary Name: PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A204559
Product Number: 001
Approval Date: Apr 13, 2015
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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