Application 019797

Type: NDA
Sponsor: BRAINTREE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NULYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	FOR SOLUTION;ORAL	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	Yes	Yes
002	NULYTELY-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	FOR SOLUTION;ORAL	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10572-302	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-302	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-302	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10572-400	PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride	polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride	Affordable Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
52268-302	NuLYTELY	polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-302	NuLYTELY	polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-302	NuLYTELY	polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-400	NuLYTELY With Flavor Packs	Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-400	NuLYTELY With Flavor Packs	Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-400	NuLYTELY With Flavor Packs	Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride	Braintree Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67524	SUPPL	2021-05-18
67494	SUPPL	2021-05-17
43625	ORIG	2013-10-03
19227	SUPPL	2013-09-24
11724	SUPPL	2013-09-23
1627	SUPPL	2004-06-18