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FDA NDA · NDA020239

KYTRIL

Sponsor: ROCHE

APPLICATION
NDA020239
TYPE
NDA
ORIGINAL APPROVAL
1993-12-29
LATEST ACTION
2011-04-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
KYTRIL · ReferenceDiscontinued
GRANISETRON HYDROCHLORIDE EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2011-04-29Efficacy · Supplement 23 · standard — Label ↗AP
2009-10-07Labeling · Supplement 21 · standard — Label ↗AP
2005-11-23Labeling · Supplement 18 · standard — Label ↗AP
2004-09-17Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
2004-09-17Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
2004-08-20Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
2002-11-25Manufacturing (CMC) · Supplement 11 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 9 · standardAP
2002-08-16Efficacy · Supplement 8 · standard — Letter ↗AP
1997-05-30Manufacturing (CMC) · Supplement 6 · standardAP
1997-03-20Labeling · Supplement 7 · standard — Review ↗AP
1997-01-21Efficacy · Supplement 4 · standardAP
1997-01-21Labeling · Supplement 2 · standardAP
1996-10-24Manufacturing (CMC) · Supplement 5 · standardAP
1995-11-21Labeling · Supplement 3 · standardAP
1994-03-11Manufacturing (CMC) · Supplement 1 · standardAP
1993-12-29Type 1 - New Molecular Entity · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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