APPLICATION
ANDA091234
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-12
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DESOGESTREL AND ETHINYL ESTRADIOLPrescription
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 12 · standardAP
2017-08-09Labeling · Supplement 5 · standardAP
2016-05-26Labeling · Supplement 3 · standardAP
2014-12-01Labeling · Supplement 1 · standardAP
2013-07-12OriginalAP
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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