norethindrone acetate and ethinyl estradiol
norethindrone acetate and ethinyl estradiol is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including BLISOVI FE 1.5/30, Blisovi Fe 1/20, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. Available dosage forms: kit, tablet.
Drug Details
- Generic Name
- norethindrone acetate and ethinyl estradiol
- Brand Names
- BLISOVI FE 1.5/30, Blisovi Fe 1/20, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, Jinteli, LUIZZA 1.5/30, LUIZZA 1/20, Blisovi 24 Fe
- Application Number
- ANDA201585
- Sponsor
- Lupin Pharmaceuticals, Inc.
- NDC Codes
- 11
- Dosage Forms
- KIT, TABLET
- Routes
- ORAL
- Active Ingredients
- ETHINYL ESTRADIOL, NORETHINDRONE ACETATE
Indications and Usage
1 INDICATION S AND USAGE TAYTULLA is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. TAYTULLA is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) The efficacy of TAYTULLA in females of reproductive potential with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated ( 1 , 8.8 )