← FDA DRUG APPROVALS

FDA ANDA · ANDA090719

LEVONEST

levonorgestrel and ethinyl estradiol

Sponsor: NOVAST LABS LTD

APPLICATION
ANDA090719
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-29
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVONESTPrescription
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 8 · standardAP
2022-02-16Labeling · Supplement 5 · standardAP
2017-08-09Labeling · Supplement 2 · standardAP
2010-12-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →