APPLICATION
ANDA077551
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-27
LATEST ACTION
2015-01-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2015-01-20Labeling · Supplement 7 · standardAP
2015-01-20Labeling · Supplement 6 · standardAP
2013-04-08Labeling · Supplement 5 · standardAP
2013-04-08Labeling · Supplement 3 · standardAP
2007-06-27OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.