← FDA DRUG APPROVALS

FDA ANDA · ANDA200670

LEVONORGESTREL

Sponsor: FDN CONSUMER

APPLICATION
ANDA200670
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-12
LATEST ACTION
2016-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVONORGESTRELDiscontinued
LEVONORGESTREL 1.5MG · TABLET · ORAL

Approval history

2016-08-19Labeling · Supplement 7 · standardAP
2014-03-11Labeling · Supplement 6 · standardAP
2012-07-12Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →