norethindrone acetate and ethinyl estradiol
Drug Details
- Generic Name
- norethindrone acetate and ethinyl estradiol
- Brand Names
- LUIZZA 1.5/30, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, Jinteli, BLISOVI FE 1.5/30, LUIZZA 1/20, Blisovi 24 Fe, Blisovi Fe 1/20
- Application Number
- ANDA202770
- Sponsor
- Xiromed LLC
- NDC Codes
- 11
- Dosage Forms
- TABLET, KIT
- Routes
- ORAL
- Active Ingredients
- ETHINYL ESTRADIOL, NORETHINDRONE ACETATE
Indications and Usage
1 INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. -------------INDICATIONS AND USAGE------------- Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy (1) Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy (1, 8.8)