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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090231

PEG 3350 AND ELECTROLYTES (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS)
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Marketing Status: Prescription
Active Ingredient: POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Proprietary Name: PEG 3350 AND ELECTROLYTES
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090231
Product Number: 001
Approval Date: Jun 1, 2009
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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