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FDA ANDA · ANDA079032

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: AM REGENT

APPLICATION
ANDA079032
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-18
LATEST ACTION
2015-01-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
ONDANSETRONPrescription
ONDANSETRON 4MG/2ML · INJECTABLE · INJECTION

Approval history

2015-01-15Labeling · Supplement 5 · standardAP
2013-01-04Labeling · Supplement 3 · standardAP
2008-11-18OriginalAP
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.

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