APPLICATION
ANDA201887
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-07
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENSKYCEPrescription
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 19 · standardAP
2019-11-15Manufacturing (CMC) · Supplement 15 · unknownAP
2019-05-23Labeling · Supplement 10 · standardAP
2019-05-23Labeling · Supplement 8 · standardAP
2019-05-23Manufacturing (CMC) · Supplement 13 · unknownAP
2017-08-09Labeling · Supplement 6 · standardAP
2016-06-02Labeling · Supplement 4 · standardAP
2015-06-19Manufacturing (CMC) · Supplement 3 · unknownAP
2015-04-01Labeling · Supplement 2 · standardAP
2013-03-07Not 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.
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.