← FDA DRUG APPROVALS

FDA NDA · NDA021238

KYTRIL

Sponsor: ROCHE

APPLICATION
NDA021238
TYPE
NDA
ORIGINAL APPROVAL
2001-06-27
LATEST ACTION
2009-10-07
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2009-10-07Labeling · Supplement 7 · standard — Label ↗AP
2005-11-23Labeling · Supplement 5 · standard — Letter ↗AP
2002-11-25Manufacturing (CMC) · Supplement 3 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 1 · standardAP
2001-06-27Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →