APPLICATION
ANDA201886
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-26
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VYFEMLAPrescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 10 · standardAP
2020-02-04Manufacturing (CMC) · Supplement 9AP
2017-08-09Labeling · Supplement 4 · standardAP
2013-09-26Not Applicable · OriginalAP
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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