APPLICATION
ANDA078846
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-27
LATEST ACTION
2023-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
Approval history
2023-07-20Labeling · Supplement 3 · standardAP
2023-07-20Labeling · Supplement 4 · standardAP
2014-09-18Labeling · Supplement 2 · standardAP
2010-09-23Labeling · Supplement 1AP
2009-02-27OriginalAP
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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