APPLICATION
ANDA076876
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-22
LATEST ACTION
2014-12-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2014-12-19Labeling · Supplement 14 · standardAP
2014-12-19Labeling · Supplement 12 · standardAP
2013-08-30Labeling · Supplement 8 · standardAP
2012-02-10Labeling · Supplement 7AP
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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