Drugs@FDA: FDA-Approved Drugs
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| GRANISETRON HYDROCHLORIDE | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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| EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
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. |
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11/05/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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01/21/1997 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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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. |
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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 |