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FDA ANDA · ANDA200910
XULANE
norelgestromin and ethinyl estradiol
Sponsor: MYLAN TECHNOLOGIES
APPLICATION
ANDA200910
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-16
LATEST ACTION
2022-04-29
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
XULANEPrescription
ETHINYL ESTRADIOL 0.035MG/24HR, NORELGESTROMIN 0.15MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2022-04-29Labeling · Supplement 14 · standardAP
2020-12-31Labeling · Supplement 10 · standardAP
2020-04-24Labeling · Supplement 8 · standardAP
2017-08-09Labeling · Supplement 5 · standardAP
2017-07-14Labeling · Supplement 3 · standardAP
2017-07-14Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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