APPLICATION
ANDA200245
TYPE
ANDA
ORIGINAL APPROVAL
2013-10-09
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 8 · standardAP
2017-08-09Labeling · Supplement 5 · standardAP
2017-07-28Manufacturing (CMC) · Supplement 1 · unknownAP
2013-10-09Not 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.