APPLICATION
ANDA077840
TYPE
ANDA
ORIGINAL APPROVAL
2007-01-19
LATEST ACTION
2016-05-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2016-05-12Labeling · Supplement 6 · standardAP
2014-12-08Labeling · Supplement 4 · standardAP
2014-12-08Labeling · Supplement 5 · standardAP
2013-01-11Labeling · Supplement 2 · standardAP
2007-01-19OriginalAP
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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