Application 021065

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEMHRT	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	0.0025MG;0.5MG	No	No
002	FEMHRT	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	0.005MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0430-0145	femhrt	norethindrone acetate/ethinyl estradiol	Allergan, Inc.	NDA	Current
0430-0145	femhrt	norethindrone acetate/ethinyl estradiol	Allergan, Inc.	NDA	Current
52544-236	Jevantique Lo	Norethindrone Acetate and Ethinyl Estradiol	Actavis Pharma, Inc.	NDA	Current