APPLICATION
ANDA077517
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2018-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 24MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
Approval history
2018-03-08Labeling · Supplement 10 · standardAP
2015-01-15Labeling · Supplement 9 · standardAP
2015-01-15Labeling · Supplement 7 · standardAP
2013-03-12Labeling · Supplement 3AP
2012-04-30Labeling · Supplement 5AP
2007-06-25UNKNOWN · Supplement 2 · standardAP
2007-06-25OriginalAP
2007-06-25UNKNOWN · Supplement 1 · standardAP
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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