Tri-Estarylla

Product manufactured by Xiromed, Llc.

Application Nr Approved Date Route Status External Links
ANDA090793 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tri-Estarylla™ (norgestimate And Ethinyl Estradiol Tablets),is An Estrogen/progestin Cocs, Indicated For Use By Women To Prevent Pregnancy. ( 1.1 ) Tri-Estarylla™ 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-Estarylla™ 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-Estarylla™ (norgestimate And Ethinyl Estradiol Tablets) Is Indicated For Use By Females Of Reproductive Potential To Prevent Pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-Estarylla™ 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-Estarylla™ Should Be Used For The Treatment Of Acne Only If The Patient Desires An Oral Contraceptive For Birth Control [see Clinical Studies ( 14 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Norgestimate And Ethinyl Estradiol

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