← FDA DRUG APPROVALS

FDA ANDA · ANDA078706

ZALEPLON

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA078706
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-06
LATEST ACTION
2014-03-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZALEPLONDiscontinued
ZALEPLON 10MG · CAPSULE · ORAL
ZALEPLONDiscontinued
ZALEPLON 5MG · CAPSULE · ORAL

Approval history

2014-03-26Labeling · Supplement 4 · standardAP
2008-09-03Labeling · Supplement 2AP
2008-06-06Original — Other Important Information from FDA ↗AP
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 →