Norelgestromin and Ethinly Estradiol

FDA Drug Profile — Norelgestromin and Ethinly Estradiol

Drug Details

Generic Name
Norelgestromin and Ethinly Estradiol
Brand Names
Norelgestromin and Ethinly Estradiol
Application Number
ANDA213950
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
1
Dosage Forms
PATCH
Routes
TRANSDERMAL
Active Ingredients
ETHINYL ESTRADIOL, NORELGESTROMIN

Indications and Usage

1 INDICATIONS AND USAGE Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use : Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m 2 [see Contraindications (4) , Warnings and Precautions (5.1) and Clinical Studies (14) ] . Norelgestromin and ethinyl estradiol transdermal system is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 ) Limitations of Use : Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women at or above 198 lbs (90 kg). ( 1 , 4 , 14 )