norethindrone acetate
Drug Details
- Generic Name
- norethindrone acetate
- Brand Names
- Norethindrone acetate
- Application Number
- ANDA206490
- Sponsor
- Ingenus Pharmaceuticals, LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- 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)