levonorgestrel and ethinyl estradiol and ethinyl estradiol

FDA Drug Profile — LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, Rosyrah

Drug Details

Generic Name
levonorgestrel and ethinyl estradiol and ethinyl estradiol
Brand Names
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, Rosyrah
Application Number
ANDA206053
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
KIT
Routes
ORAL
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE Simpesse ® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Simpesse is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )