← FDA DRUG APPROVALS

FDA NDA · NDA020305

KYTRIL

Sponsor: ROCHE

APPLICATION
NDA020305
TYPE
NDA
ORIGINAL APPROVAL
1995-03-16
LATEST ACTION
2009-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** · TABLET · ORAL
KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2009-10-07Labeling · Supplement 14 · standard — Label ↗AP
2005-11-23Labeling · Supplement 10 · standard — Review ↗AP
2002-11-25Manufacturing (CMC) · Supplement 8 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 6 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 5 · standardAP
1999-07-27Efficacy · Supplement 4 · standard — Review ↗AP
1998-06-15Manufacturing (CMC) · Supplement 3 · standardAP
1997-10-06Efficacy · Supplement 1 · standard — Review ↗AP
1996-10-24Manufacturing (CMC) · Supplement 2 · standardAP
1995-03-16Type 3 - New Dosage Form · Original · standardAP
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.

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