APPLICATION
ANDA078835
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2015-07-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2015-07-15Labeling · Supplement 13 · standardAP
2014-09-18Labeling · Supplement 12 · standardAP
2012-04-17Labeling · Supplement 8AP
2010-01-28Labeling · Supplement 6AP
2008-06-30OriginalAP
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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