estradiol
Drug Details
- Generic Name
- estradiol
- Brand Names
- ESTRADIOL VAGINAL INSERTS, Estradiol, ESTRADIOL, Estradiol Vaginal, Minivelle, Vivelle-Dot, IMVEXXY, Estradiol Vaginal Cream, estradiol, Imvexxy, Menostar, ESTRACE, DIVIGEL, EstroGel
- Application Number
- ANDA210264
- Sponsor
- Catalent Pharma Solutions LLC
- NDC Codes
- 50
- Dosage Forms
- INSERT, TABLET, FILM COATED, PATCH, GEL, CREAM, FILM, EXTENDED RELEASE, PATCH, EXTENDED RELEASE, GEL, METERED
- Routes
- VAGINAL, TRANSDERMAL, TOPICAL
- Active Ingredients
- ESTRADIOL
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/m2 [ 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 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 )