APPLICATION
ANDA077187
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2014-09-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2014-09-18Labeling · Supplement 5 · standardAP
2014-08-29Labeling · Supplement 4 · standardAP
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.
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.