← FDA DRUG APPROVALS

FDA ANDA · ANDA203087

ESZOPICLONE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA203087
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-08
LATEST ACTION
2019-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESZOPICLONEDiscontinued
ESZOPICLONE 3MG · TABLET · ORAL
ESZOPICLONEDiscontinued
ESZOPICLONE 1MG · TABLET · ORAL
ESZOPICLONEDiscontinued
ESZOPICLONE 2MG · TABLET · ORAL

Approval history

2019-05-08UNKNOWN · 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 →