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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020305
Company: ROCHE

Products on NDA 020305

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KYTRIL	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
KYTRIL	GRANISETRON HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020305

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/1995	ORIG-1	Approval	Type 3 - New Dosage Form	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
10/07/2009	SUPPL-14	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-10	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020305s010,021238s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020305_s010_Kytril Tabs.pdf
11/25/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/05/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/27/1999	SUPPL-4	Efficacy-New Indication	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20103s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020305S004_Kytril.html
06/15/1998	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/24/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/06/1997	SUPPL-1	Efficacy-New Dosing Regimen	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020305a_s001.pdf

Labels for NDA 020305

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2009	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf
11/23/2005	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf

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