Application 211358

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORKAMBI	IVACAFTOR; LUMACAFTOR	GRANULE;ORAL	125MG/PACKET;100MG/PACKET	Yes	No
002	ORKAMBI	IVACAFTOR; LUMACAFTOR	GRANULE;ORAL	188MG/PACKET;150MG/PACKET	Yes	Yes
003	ORKAMBI	IVACAFTOR; LUMACAFTOR	GRANULE;ORAL	94MG/PACKET;75MG/PACKET	Yes	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-122	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-122	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-500	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-500	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-500	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-500	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-500	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-500	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-900	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-900	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-900	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-900	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-900	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-900	ORKAMBI	lumacaftor and ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current