estradiol valerate and estradiol valerate/dienogest
estradiol valerate and estradiol valerate/dienogest is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Natazia, Estradiol Valerate and Estradiol Valerate/Dienogest. Available dosage form: kit.
Drug Details
- Generic Name
- estradiol valerate and estradiol valerate/dienogest
- Brand Names
- Natazia, Estradiol Valerate and Estradiol Valerate/Dienogest
- Application Number
- NDA022252
- Sponsor
- Bayer HealthCare Pharmaceuticals Inc.
- NDC Codes
- 2
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE • Estradiol Valerate and Estradiol Valerate/Dienogest is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 ) • Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception. ( 1.2 ) • The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in women with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. ( 1 , 8.8 ) 1.1 Oral Contraception Estradiol Valerate and Estradiol Valerate/Dienogest is indicated for use by women to prevent pregnancy. The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in women with a body mass index (BMI) of > 30 kg/m 2 has not been evaluated. 1.2 Heavy Menstrual Bleeding Estradiol Valerate and Estradiol Valerate/Dienogest is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see Clinical Studies ( 14.2 )].