PROVEPHARM SAS Application 216264

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BLUDIGO	INDIGOTINDISULFONATE SODIUM	SOLUTION; INJECTION	40MG/5ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81284-315	BLUDIGO	indigotindisulfonate sodium	Provepharm Inc.	NDA	Current
81284-315	BLUDIGO	indigotindisulfonate sodium	Provepharm Inc.	NDA	Current