Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019011

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GOLYTELY (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: GOLYTELY
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: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N019011
Product Number: 001
Approval Date: Jul 13, 1984
Applicant Holder Full Name: BRAINTREE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GOLYTELY (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS)
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET
Marketing Status: Discontinued

Active Ingredient: POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Proprietary Name: GOLYTELY
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019011
Product Number: 002
Approval Date: Jun 2, 1992
Applicant Holder Full Name: BRAINTREE LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information