APPLICATION
ANDA202380
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-29
LATEST ACTION
2022-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LEVONORGESTRELOver-the-counter
LEVONORGESTREL 1.5MG · TABLET · ORAL
Approval history
2022-10-25Labeling · Supplement 4 · standardAP
2016-09-13Labeling · Supplement 1 · standardAP
2015-05-29UNKNOWN · 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.