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FDA ANDA · ANDA078945

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: AVET LIFESCIENCES

APPLICATION
ANDA078945
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-03
LATEST ACTION
2026-05-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2026-05-01Labeling · Supplement 22 · standardAP
2023-01-20Labeling · Supplement 20 · standardAP
2021-08-18Labeling · Supplement 14 · standardAP
2021-08-18Labeling · Supplement 19 · standardAP
2015-01-14Labeling · Supplement 5 · standardAP
2015-01-14Labeling · Supplement 1 · standardAP
2015-01-14Labeling · Supplement 8 · standardAP
2013-01-03OriginalAP
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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