Application 022239

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	Yes	No
002	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43376-104	Sumavel DosePro	sumatriptan	Zogenix, Inc.	NDA	Current
43376-106	Sumavel DosePro	sumatriptan	Zogenix, Inc.	NDA	Current
63481-367	Sumavel DosePro	sumatriptan	Endo Pharmaceuticals, Inc.	NDA	Current