Application 076762

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 5MG BASE	No	No
002	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 10MG BASE	No	No
003	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 25MG BASE	No	No
004	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 50MG BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7005	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7010	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7025	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7050	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-3457	Loxapine	loxapine	A-S Medication Solutions	ANDA	Current
51079-901	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-901	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-902	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-902	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-903	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
70518-0995	Loxapine	loxapine	REMEDYREPACK INC.	ANDA	Current
70518-0995	Loxapine	loxapine	REMEDYREPACK INC.	ANDA	Current