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FDA ANDA · ANDA077544

ONDANSETRON HYDROCHLORIDE

Sponsor: PLIVA HRVATSKA DOO

APPLICATION
ANDA077544
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2021-06-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION

Approval history

2021-06-07Labeling · Supplement 3 · standardAP
2021-06-07Labeling · Supplement 2 · standardAP
2006-12-26OriginalAP
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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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