Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020305
Company: ROCHE
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KYTRIL GRANISETRON HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
KYTRIL GRANISETRON HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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.cfm
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
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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