APPLICATION
ANDA077502
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-23
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MYZILRADiscontinued
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 8 · standardAP
2017-08-09Labeling · Supplement 7 · standardAP
2014-08-04Manufacturing (CMC) · Supplement 4 · unknownAP
2011-11-23OriginalAP
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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