Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020239
Company: ROCHE
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KYTRIL GRANISETRON HYDROCHLORIDE EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
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.

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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