Norgestimate

FDA Drug Profile

Drug Details

Generic Name
Norgestimate
Brand Names
N/A
Application Number
Sponsor
Gedeon Richter Plc.
NDC Codes
2
Dosage Forms
CRYSTAL, POWDER
Routes
N/A
Active Ingredients
NORGESTIMATE

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) ] .