Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020007
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOFRAN | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZOFRAN PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020007s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020007Orig1s049ltr.pdf | |
| 04/29/2021 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020007s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020007Orig1s048ltr.pdf | |
| 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)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/20007Orig1s041.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 |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020007s049lbl.pdf | |
| 04/29/2021 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020007s048lbl.pdf | |
| 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 |