Application 209500

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPLYTA	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	EQ 42MG BASE	Yes	Yes
002	CAPLYTA	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	EQ 10.5MG BASE	Yes	No
003	CAPLYTA	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	EQ 21MG BASE	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3497	CAPLYTA	lumateperone	REMEDYREPACK INC.	NDA	Current
72060-110	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-110	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-121	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-121	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current