APPLICATION
ANDA213977
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-25
LATEST ACTION
2022-04-29
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ONSURAPrescription
ETHINYL ESTRADIOL 0.035MG/24HR, NORELGESTROMIN 0.15MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2022-04-29Labeling · Supplement 1 · standardAP
2021-08-25UNKNOWN · Original · 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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