Application 210491

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	TABLET, TABLET;ORAL	150MG,N/A;150MG, 100MG	Yes	Yes
002	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	TABLET, TABLET;ORAL	75MG,N/A;75MG, 50MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-113	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-661	SYMDEKO	Tezacaftor and Ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current