Application Nr Approved Date Route Status External Links
ANDA200910 None Transdermal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Xulane Is Indicated For The Prevention Of Pregnancy In Women With A Body Mass Index (bmi) < 30 Kg/m 2 For Whom A Transdermal Delivery System Is An Appropriate Method Of Contraception . Limitations Of Use: Xulane May Be Less Effective In Preventing Pregnancy In Women Who Weigh 198 Lbs. (90 Kg) Or More. Xulane Is Contraindicated For Use In Women With Bmi ≥ 30 Kg/m 2 [see Contraindications (4) , Warnings And Precautions (5.1) And Clinical Studies (14) ] . Xulane Is An Estrogen/progestin Combination Hormonal Contraceptive (chc), Indicated For The Prevention Of Pregnancy In Women With A Bmi < 30 Kg/m 2 For Whom A Transdermal Delivery System Is An Appropriate Method Of Contraception. ( 1 ) Limitations Of Use: Xulane May Be Less Effective In Preventing Pregnancy In Women At Or Above 198 Lbs. (90 Kg). ( 1 , 4 , 14 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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

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