Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets
Drug Details
- Generic Name
- Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets
- Brand Names
- Norethindrone Acetate and Ethinyl Estradiol
- Application Number
- ANDA209609
- Sponsor
- Xiromed, LLC
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- ORAL
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is an estrogen/progestin COC indicated for use by women to prevent pregnancy ( 1 ) The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )