segesterone acetate and ethinyl estradiol

FDA Drug Profile — Annovera

segesterone acetate and ethinyl estradiol is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Annovera. Available dosage form: ring.

Drug Details

Generic Name
segesterone acetate and ethinyl estradiol
Brand Names
Annovera
Application Number
NDA209627
Sponsor
Mayne Pharma
NDC Codes
1
Dosage Forms
RING
Routes
VAGINAL
Active Ingredients
SEGESTERONE ACETATE, ETHINYL ESTRADIOL

Indications and Usage

1 INDICATIONS AND USAGE ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. ANNOVERA is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Usage Not adequately evaluated in females with a body mass index of >29 kg/m 2 . ( 1 ) Limitations of Use ANNOVERA has not been adequately studied in females with a BMI >29 kg/m 2 .