Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020103
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOFRAN | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZOFRAN | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZOFRAN | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s038,020605s022,020781s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020103Orig1s038,020605Orig1s022,020781Orig1s022ltr.pdf | |
| 04/29/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s037,020605s021,020781s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/20103s037,20605s021,20781s021ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s038,020605s022,020781s022lbl.pdf | |
| 04/29/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s037,020605s021,020781s021lbl.pdf | |
| 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 |