Application Nr Approved Date Route Status External Links
NDA019697 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ortho-Cyclen And Ortho Tri-Cyclen Are Estrogen/progestin Cocs, Indicated For Use By Women To Prevent Pregnancy. ( 1.1 ) Ortho Tri-Cyclen 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. Ortho Tri-Cyclen 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 Ortho-Cyclen And Ortho Tri-Cyclen Tablets Are Indicated For Use By Females Of Reproductive Potential To Prevent Pregnancy [See Clinical Studies (14) ] . 1.2 Acne Ortho Tri-Cyclen 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. Ortho Tri-Cyclen 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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