APPLICATION
ANDA077842
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-31
LATEST ACTION
2022-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GRANISETRON HYDROCHLORIDEDiscontinued
GRANISETRON HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
Approval history
2022-08-12Labeling · Supplement 14 · standardAP
2014-11-04Manufacturing (CMC) · Supplement 3AP
2014-09-18Labeling · Supplement 12 · standardAP
2010-06-07Labeling · Supplement 6AP
2008-11-24Labeling · Supplement 1AP
2007-12-31OriginalAP
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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