Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020103
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription AB Yes No
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription AB Yes No
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/31/1992 ORIG-1 Approval Type 3 - New Dosage Form 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
10/05/2017 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020103Orig1s036,020605Orig1s020,020781Orig1s020ltr.pdf
11/09/2016 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s035,020605Orig1s019,020781Orig1s019ltr.pdf
09/18/2014 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf
09/28/2016 SUPPL-33 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf
12/10/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf
09/14/2011 SUPPL-30 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf
09/22/2010 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf
08/22/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf
12/27/2005 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020103_s025_Zofran Inj.pdf
02/18/2005 SUPPL-24 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20103s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20103s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020103_s024_Zofran Tabs.pdf
11/24/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf
01/31/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20103slr021,20781slr003ltr.pdf
10/24/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/2000 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF
04/11/2000 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020103_S017_ZOFRAN.pdf
08/27/1999 SUPPL-16 Manufacturing (CMC)-Formulation Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran.cfm
08/27/1999 SUPPL-15 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran.cfm
04/15/1997 SUPPL-13 Labeling

Label is not available on this site.

11/16/1995 SUPPL-11 Labeling

Label is not available on this site.

05/17/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/14/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf
04/27/1994 SUPPL-7 Labeling

Label is not available on this site.

04/15/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/19/1995 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

09/26/1994 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

04/04/1994 SUPPL-3 Labeling

Label is not available on this site.

09/28/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1993 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
10/05/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf
11/09/2016 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf
09/18/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf
12/10/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf
09/14/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf
09/14/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf
09/22/2010 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf
08/22/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf
12/27/2005 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf
02/18/2005 SUPPL-24 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20103s024lbl.pdf
11/24/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf
12/13/2000 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF
04/10/1995 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf

ZOFRAN

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077306 APOTEX
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 078539 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077517 CASI PHARMS INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076183 DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077535 GLENMARK GENERICS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 203761 IPCA LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076930 MYLAN
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077851 NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077112 PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077050 SUN PHARM INDS (IN)
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076252 TEVA
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription Yes AB 020103 NOVARTIS PHARMS CORP

TABLET;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077306 APOTEX
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 078539 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077517 CASI PHARMS INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 076183 DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077535 GLENMARK GENERICS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 203761 IPCA LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 076930 MYLAN
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077851 NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077112 PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077050 SUN PHARM INDS (IN)
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 076252 TEVA
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription Yes AB 020103 NOVARTIS PHARMS CORP

TABLET;ORAL; EQ 24MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 078539 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 077517 CASI PHARMS INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 076183 DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 077535 GLENMARK GENERICS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 077112 PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 076252 TEVA
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription Yes AB 020103 NOVARTIS PHARMS CORP

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