EXELA PHARMA Application 215870

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL CITRATE	FENTANYL CITRATE	SOLUTION;INTRAVENOUS	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No
002	FENTANYL CITRATE	FENTANYL CITRATE	SOLUTION;INTRAVENOUS	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No