APPLICATION
ANDA076915
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-29
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 21 · standardAP
2017-08-09Labeling · Supplement 20 · standardAP
2015-04-13Labeling · Supplement 13 · standardAP
2013-06-28Labeling · Supplement 11 · standardAP
2010-07-28Labeling · Supplement 10AP
2005-07-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.