Application 022542

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIOKACE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	TABLET;ORAL	39,150USP UNITS;10,440USP UNITS;39,150USP UNITS	No	No
002	VIOKACE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	TABLET;ORAL	78,300USP UNITS;20,880USP UNITS;78,300USP UNITS	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58914-112	Viokace	Pancrelipase	Allergan, Inc.	BLA	Current
58914-112	Viokace	Pancrelipase	Allergan, Inc.	BLA	Current
58914-112	Viokace	Pancrelipase	Allergan, Inc.	NDA	Current
58914-117	Viokace	Pancrelipase	Allergan, Inc.	BLA	Current
58914-117	Viokace	Pancrelipase	Allergan, Inc.	BLA	Current
58914-117	Viokace	Pancrelipase	Allergan, Inc.	NDA	Current
73562-104	Viokace	Pancrelipase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-104	Viokace	Pancrelipase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-208	Viokace	Pancrelipase	Nestle Healthcare Nutrition, Inc.	BLA	Current
73562-208	Viokace	Pancrelipase	Nestle Healthcare Nutrition, Inc.	BLA	Current