Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019797

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NULYTELY (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: NULYTELY
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N019797
Product Number: 001
Approval Date: Apr 22, 1991
Applicant Holder Full Name: BRAINTREE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NULYTELY-FLAVORED (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: NULYTELY-FLAVORED
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N019797
Product Number: 002
Approval Date: Nov 18, 1994
Applicant Holder Full Name: BRAINTREE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information