Application 206038

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORKAMBI	IVACAFTOR; LUMACAFTOR	TABLET;ORAL	125MG;200MG	Yes	Yes
002	ORKAMBI	IVACAFTOR; LUMACAFTOR	TABLET;ORAL	125MG;100MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-700	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-809	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current