Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022465
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOTRIENT | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| VOTRIENT | PAZOPANIB HYDROCHLORIDE | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/19/2009 | ORIG-1 | Approval | Type 1 - New Molecular Entity | UNKNOWN |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022465s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/25/2024 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022465s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022465Orig1s036ltr.pdf | |
| 12/13/2021 | SUPPL-33 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022465Orig1s033ltr.pdf | |
| 09/22/2021 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022465Orig1s031, s032ltr.pdf | |
| 09/22/2021 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022465Orig1s031, s032ltr.pdf | |
| 07/17/2020 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022465Orig1s030ltr.pdf | |
| 08/17/2020 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022465Orig1s029ltr.pdf | |
| 06/02/2020 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022465Orig1s028ltr.pdf | |
| 05/31/2017 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022465Orig1s024s025ltr.pdf | |
| 05/31/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022465Orig1s024s025ltr.pdf | |
| 08/05/2016 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s023ltr.pdf | |
| 05/20/2016 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s022ltr.pdf | |
| 09/22/2015 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s021ltr.pdf | |
| 04/01/2015 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Label (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s020ltr.pdf | |
| 11/18/2014 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s019ltr.pdf | |
| 06/03/2014 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s018ltr.pdf | |
| 11/27/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s017ltr.pdf | |
| 08/14/2013 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf | |
| 08/14/2013 | SUPPL-15 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf | |
| 08/14/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf | |
| 11/15/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465Orig1s013ltr.pdf | |
| 04/26/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf | |
| 03/20/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s011ltr.pdf | |
| 04/26/2012 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf | |
| 01/12/2012 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s007ltr.pdf | |
| 04/21/2011 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s006ltr.pdf |
| 10/21/2011 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf | |
| 10/21/2011 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf | |
| 04/27/2010 | SUPPL-2 | Labeling-Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022465s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/25/2024 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022465s036lbl.pdf | |
| 12/13/2021 | SUPPL-33 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465Orig1s033lbl.pdf | |
| 09/22/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf | |
| 09/22/2021 | SUPPL-32 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf | |
| 09/22/2021 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf | |
| 09/22/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf | |
| 08/17/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s029lbl.pdf | |
| 08/17/2020 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s029lbl.pdf | |
| 07/17/2020 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s030lbl.pdf | |
| 06/02/2020 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s028lbl.pdf | |
| 06/02/2020 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022465s028lbl.pdf | |
| 05/31/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf | |
| 05/31/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf | |
| 08/05/2016 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s023lbl.pdf | |
| 05/20/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf | |
| 09/22/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf | |
| 04/01/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf | |
| 04/01/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf | |
| 11/18/2014 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf | |
| 06/03/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s018lbl.pdf | |
| 11/27/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s017lbl.pdf | |
| 08/14/2013 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf | |
| 08/14/2013 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf | |
| 08/14/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf | |
| 11/15/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013lbl.pdf | |
| 04/26/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf | |
| 04/26/2012 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf | |
| 03/20/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf | |
| 01/12/2012 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s007lbl.pdf | |
| 10/21/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf | |
| 10/21/2011 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf | |
| 10/21/2011 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf | |
| 04/27/2010 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf | |
| 04/27/2010 | SUPPL-2 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf | |
| 10/19/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf |
VOTRIENT
TABLET;ORAL; EQ 200MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 217713 | APOTEX |
| PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 219034 | EUGIA PHARMA |
| PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 218231 | NOVUGEN |
| PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 215837 | SUN PHARM |
| PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 217517 | TEVA PHARMS INC |
| VOTRIENT | PAZOPANIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022465 | NOVARTIS |