norgestimate and ethinyl estradiol

FDA Drug Profile — Nymyo, TRI-LO-MARZIA, norgestimate and ethinyl estradiol, MONO-LINYAH, Tri-Lo- Estarylla

norgestimate and ethinyl estradiol is listed in the FDA National Drug Code directory with 22 NDC codes, marketed under brand names including Nymyo, TRI-LO-MARZIA, norgestimate and ethinyl estradiol. Available dosage form: kit.

Drug Details

Generic Name
norgestimate and ethinyl estradiol
Brand Names
Nymyo, TRI-LO-MARZIA, norgestimate and ethinyl estradiol, MONO-LINYAH, Tri-Lo- Estarylla, Tri-Estarylla, Tri-Sprintec, Tri Femynor, Mili, VyLibra, Mono-Linyah, Femynor, Norgestimate and Ethinyl Estradiol
Application Number
ANDA090523
Sponsor
Mayne Pharma Inc.
NDC Codes
22
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] .