APPLICATION
ANDA091440
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-23
LATEST ACTION
2026-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL
Approval history
2026-06-16Labeling · Supplement 11 · standardAP
2026-06-16Labeling · Supplement 6 · standardAP
2026-06-16Labeling · Supplement 4 · standardAP
2026-06-16Labeling · Supplement 10 · standardAP
2012-10-23OriginalAP
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.
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.