APPLICATION
ANDA073592
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-13
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEVORA 0.15/30-21Discontinued
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-21
Approval history
2022-04-29Labeling · Supplement 22 · standardAP
2022-03-09Labeling · Supplement 21 · standardAP
2017-08-09Labeling · Supplement 20 · standardAP
2001-08-16Manufacturing (CMC) · Supplement 6AP
1996-10-31Manufacturing (CMC) · Supplement 3AP
1996-07-10Labeling · Supplement 2AP
1996-06-10Manufacturing (CMC) · Supplement 1AP
1993-12-13OriginalAP
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.