norgestimate and ethinyl estradiol

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

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

Drug Details

Generic Name
norgestimate and ethinyl estradiol
Brand Names
norgestimate and ethinyl estradiol, Tri-Sprintec, Tri-Estarylla, Nymyo, TRI-LO-MARZIA, Norgestimate and Ethinyl Estradiol, VyLibra, Tri-Lo- Estarylla, Femynor, MONO-LINYAH, Tri Femynor, Mono-Linyah, Mili
Application Number
ANDA200541
Sponsor
PD-Rx Pharmaceuticals, 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) ] .