BRAINTREE LABS Application 211281

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIZENSY	LACTITOL	FOR SOLUTION;ORAL	10GM	Yes	Yes
002	PIZENSY	LACTITOL	SOLUTION;ORAL	20G	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52268-600	PIZENSY	lactitol	Braintree Laboratories, Inc.	NDA	Current
52268-600	PIZENSY	lactitol	Braintree Laboratories, Inc.	NDA	Current