APPLICATION
ANDA091137
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-09
LATEST ACTION
2016-11-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2016-11-08Labeling · Supplement 10 · standardAP
2014-09-18Labeling · Supplement 9 · standardAP
2014-09-15Labeling · Supplement 8 · standardAP
2013-08-06Labeling · Supplement 6 · standardAP
2013-08-06Labeling · Supplement 4 · standardAP
2012-04-18Labeling · Supplement 2AP
2011-04-01Labeling · Supplement 1AP
2010-04-09OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.