← FDA DRUG APPROVALS

FDA ANDA · ANDA077173

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA077173
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2015-07-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION

Approval history

2015-07-02Labeling · Supplement 5 · standardAP
2015-07-02Labeling · Supplement 3 · standardAP
2006-12-26OriginalAP
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 →