Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020007
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Discontinued None Yes No
ZOFRAN PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML 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
01/04/1991 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2017 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020007s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20007Orig1s047ltr.pdf
09/18/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020007Orig1s046ltr.pdf
12/10/2013 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020007s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf
11/14/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020007Orig1s043ltr.pdf
09/14/2011 SUPPL-42 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf
07/07/2011 SUPPL-41 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf
09/22/2010 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf
08/22/2006 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf
12/27/2005 SUPPL-37 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020007_s037_Zofran Inj.pdf
03/25/2005 SUPPL-35 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20007s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20007s035ltr.pdf
11/24/2004 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf
12/08/2000 SUPPL-32 Labeling

Label is not available on this site.

12/08/2000 SUPPL-31 Labeling

Label is not available on this site.

04/11/2000 SUPPL-30 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020007_s030_Zofran_Injection.pdf
05/14/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/17/1999 SUPPL-28 Labeling

Label is not available on this site.

03/10/1999 SUPPL-27 Labeling

Label is not available on this site.

08/12/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/02/1997 SUPPL-23 Labeling

Label is not available on this site.

10/31/1997 SUPPL-22 Efficacy-New Route Of Administration Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm
03/12/1996 SUPPL-21 Labeling

Label is not available on this site.

05/16/1996 SUPPL-20 Efficacy-New Indication

Label is not available on this site.

07/29/1996 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/27/1994 SUPPL-16 Labeling

Label is not available on this site.

03/31/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/28/1993 SUPPL-13 Labeling

Label is not available on this site.

02/09/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1993 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/02/1993 SUPPL-8 Labeling

Label is not available on this site.

02/02/1993 SUPPL-7 Labeling

Label is not available on this site.

08/18/1992 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1993 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

02/02/1993 SUPPL-4 Labeling

Label is not available on this site.

02/02/1993 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

02/02/1993 SUPPL-2 Labeling

Label is not available on this site.

02/02/1993 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/08/2017 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020007s047lbl.pdf
09/18/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf
12/10/2013 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020007s044lbl.pdf
11/14/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf
09/14/2011 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf
09/14/2011 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf
09/22/2010 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf
08/22/2006 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf
12/27/2005 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf
03/25/2005 SUPPL-35 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20007s035lbl.pdf
11/24/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf

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