norgestimate and ethinyl estradiol
Drug Details
- Generic Name
- norgestimate and ethinyl estradiol
- Brand Names
- Mono-Linyah, Femynor, TRI-LO-MARZIA, Mili, Tri-Sprintec, Tri-Lo- Estarylla, Tri-Estarylla, Norgestimate and Ethinyl Estradiol, MONO-LINYAH, VyLibra, norgestimate and ethinyl estradiol, Tri Femynor, Nymyo
- Application Number
- ANDA090523
- Sponsor
- Northstar Rx LLC
- NDC Codes
- 21
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE Tri-Linyah is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Linyah is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-Linyah is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14) ] .