← FDA DRUG APPROVALS

FDA NDA · NDA022524

ZUPLENZ

Sponsor: AQUESTIVE

APPLICATION
NDA022524
TYPE
NDA
ORIGINAL APPROVAL
2010-07-02
LATEST ACTION
2021-08-05
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Discontinued

Products

ZUPLENZ · ReferenceDiscontinued
ONDANSETRON 4MG · FILM · ORAL
ZUPLENZ · ReferenceDiscontinued
ONDANSETRON 8MG · FILM · ORAL

Approval history

2021-08-05Labeling · Supplement 7 · standard — Label ↗AP
2015-06-25Manufacturing (CMC) · Supplement 4 · standardAP
2014-09-18Labeling · Supplement 3 · 901 required — Letter ↗AP
2013-10-30Labeling · Supplement 2 · standard — Label ↗AP
2010-07-02Type 3 - New Dosage Form · Original · standard — Label ↗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 →