Application 207925

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KALYDECO	IVACAFTOR	GRANULE;ORAL	50MG/PACKET	Yes	No
002	KALYDECO	IVACAFTOR	GRANULE;ORAL	75MG/PACKET	Yes	Yes
003	KALYDECO	IVACAFTOR	GRANULE;ORAL	25MG/PACKET	Yes	No
004	KALYDECO	IVACAFTOR	GRANULE;ORAL	5.8MG/PACKET	Yes	No
005	KALYDECO	IVACAFTOR	GRANULE;ORAL	13.4MG/PACKET	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-300	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-300	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-300	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-300	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-300	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-400	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-400	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-400	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-400	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-400	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-600	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-600	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-600	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-600	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current