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FDA ANDA · ANDA078014

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: TARO PHARMS IRELAND

APPLICATION
ANDA078014
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-21
LATEST ACTION
2015-11-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2015-11-30Labeling · Supplement 2 · standardAP
2008-03-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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