APPLICATION
ANDA077368
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2022-03-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2022-03-15Labeling · Supplement 10 · standardAP
2021-08-16Labeling · Supplement 9 · standardAP
2021-08-16Labeling · Supplement 8 · standardAP
2014-12-31Labeling · Supplement 7 · standardAP
2014-12-31Labeling · Supplement 5 · standardAP
2014-12-31Labeling · Supplement 6 · standardAP
2007-06-19Manufacturing (CMC) · Supplement 1AP
2007-06-19Manufacturing (CMC) · Supplement 2AP
2006-12-26OriginalAP
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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