Application Nr Approved Date Route Status External Links
ANDA207581 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Aurovela 1.5/30 Is Indicated For The Prevention Of Pregnancy In Women Who Elect To Use Oral Contraceptives As A Method Of Contraception. Oral Contraceptives Are Highly Effective. Table I Lists The Typical Accidental Pregnancy Rates For Users Of Combination Oral Contraceptives And Other Methods Of Contraception. The Efficacy Of These Contraceptive Methods, Except Sterilization, Depends Upon The Reliability With Which They Are Used. Correct And Consistent Use Of Methods Can Result In Lower Failure Rates. Table I Lowest Expected And Typical Failure Rates During The First Year Of Continuous Use Of A Method Adapted From Ra Hatcher Et Al, Reference 7. *the Authors’ Best Guess Of The Percentage Of Women Expected To Experience An Accidental Pregnancy Among Couples Who Initiate A Method (not Necessarily For The First Time) And Who Use It Consistently And Correctly During The First Year If They Do Not Stop For Any Other Reason. ** This Term Represents “typical” Couples Who Initiate Use Of A Method (not Necessarily For The First Time), Who Experience An Accidental Pregnancy During The First Year If They Do Not Stop Use For Any Other Reason. *** N/a-Data Not Available. % Of Women Experiencing An Unintended Pregnancy In The First Year Of Continuous Use Method Lowest Expected* Typical** (no Contraception) Oral Contraceptives Combined Progestin Only Diaphragm With Spermicidal Cream Or Jelly Spermicides Alone (foam, Creams, Gels, Vaginal Suppositories, And Vaginal Film) Vaginal Sponge Nulliparous Parous Implant Injection: Depot Medroxyprogesterone Acetate Iud Progesterone T Copper T 380a Lng 20 Condom Without Spermicides Female Male Cervical Cap With Spermicidal Cream Or Jelly Nulliparous Parous Periodic Abstinence (all Methods) Withdrawal Female Sterilization Male Sterilization (85) 0.1 0.5 6 6 9 20 0.05 0.3 1.5 0.6 0.1 5 3 9 26 1 To 9 4 0.5 0.1 (85) 3 N/a*** N/a*** 20 26 20 40 0.05 0.3 2 0.8 0.1 21 14 20 40 25 19 0.5 0.15

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Ethinyl Estradiol
2. Norethindrone Acetate

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