EDISON THERAPS LLC Application 006035

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	METHERGINE	METHYLERGONOVINE MALEATE	TABLET;ORAL	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	METHERGINE	METHYLERGONOVINE MALEATE	INJECTABLE;INJECTION	0.2MG/ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12634-179	METHERGINE	METHYLERGONOVINE MALEATE	Apotheca, Inc.	NDA	Current
63629-3791	Methergine	methylergonovine maleate	Bryant Ranch Prepack	NDA	Current
66336-402	Methergine	methylergonovine maleate	Dispensing Solutions, Inc.	NDA	Current