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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020239
Company: ROCHE

Products on NDA 020239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KYTRIL	GRANISETRON HYDROCHLORIDE	EQ 3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
KYTRIL	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HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
KYTRIL	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HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
KYTRIL	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HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2011	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020239s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020239s023ltr.pdf
10/07/2009	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf
11/23/2005	SUPPL-18	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020239s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020239s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s018_Kytril Inj.pdf
09/17/2004	SUPPL-17	Manufacturing (CMC)	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s017_KYTRIL.pdf
09/17/2004	SUPPL-16	Manufacturing (CMC)-Formulation	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s016_KYTRIL.pdf
08/20/2004	SUPPL-15	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20239s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s015_KYTRIL INJECTION.pdf
11/25/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/2002	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/16/2002	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21239s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20239se1-008ltr.pdf
03/20/1997	SUPPL-7	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020239_s007_KYTRIL INJ.pdf
05/30/1997	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/24/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/21/1997	SUPPL-4	Efficacy-New Dosing Regimen		Label is not available on this site.
11/21/1995	SUPPL-3	Labeling		Label is not available on this site.
01/21/1997	SUPPL-2	Labeling		Label is not available on this site.
03/11/1994	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 020239

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2011	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020239s023lbl.pdf
10/07/2009	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf
11/23/2005	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020239s018lbl.pdf
08/20/2004	SUPPL-15	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20239s015lbl.pdf
08/16/2002	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21239s8lbl.pdf

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