Application 078324

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	1MG;0.5MG	No	No
002	ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	0.5MG;0.1MG	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-474	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-474	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-474	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-474	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-474	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-623	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-623	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-623	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-623	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-623	Estradiol / Norethindrone Acetate	Estradiol and Norethindrone Acetate	Breckenridge Pharmaceutical, Inc.	ANDA	Current