Application 076081

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUNEL FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-28	0.02MG;1MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3237	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	A-S Medication Solutions	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-126	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current