APPLICATION
ANDA078969
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-22
LATEST ACTION
2022-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
Approval history
2022-08-22Labeling · Supplement 5 · standardAP
2022-08-22Labeling · Supplement 6 · standardAP
2022-08-22Labeling · Supplement 4 · standardAP
2014-10-17Labeling · Supplement 3 · standardAP
2011-12-07Labeling · Supplement 1AP
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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