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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021238
Company: ROCHE

Products on NDA 021238

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KYTRIL	GRANISETRON HYDROCHLORIDE	EQ 2MG BASE/10ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021238

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21238lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21238ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-238_Kytril.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2009	SUPPL-7	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-5	Labeling	Label (PDF) Letter (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
11/25/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021238

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2009	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf
11/23/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf
06/27/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21238lbl.pdf

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