Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021923
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEXAVAR | SORAFENIB TOSYLATE | EQ 200MG 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 |
|---|---|---|---|---|---|---|---|
| 12/01/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021923lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021923ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021923_s000_NexavarTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/28/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021923Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021923Orig1s026ltr.pdf | |
| 05/20/2021 | SUPPL-25 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021923Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021923Orig1s025ltr.pdf | |
| 07/09/2020 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s024lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021923Orig1s024ltr.pdf | |
| 04/02/2020 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021923Orig1s023ltr.pdf | |
| 06/19/2020 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021923Orig1s022ltr.pdf | |
| 12/06/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021923s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021923s020ltr.pdf | |
| 12/06/2018 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021923s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021923s019ltr.pdf | |
| 12/22/2017 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021923s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021923Orig1s018ltr.pdf | |
| 12/02/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2013 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s016ltr.pdf | |
| 10/30/2013 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s015ltr.pdf | |
| 06/11/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s014ltr.pdf | |
| 08/24/2012 | SUPPL-13 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021923Origs013ltr.pdf |
| 10/14/2011 | SUPPL-12 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s012ltr.pdf | |
| 03/22/2011 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s011ltr.pdf | |
| 10/26/2010 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf | |
| 10/26/2010 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf | |
| 11/16/2007 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf | |
| 11/16/2007 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf | |
| 11/16/2007 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf | |
| 11/16/2007 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf | |
| 03/05/2007 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/28/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021923Orig1s026lbl.pdf | |
| 05/20/2021 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021923Orig1s025lbl.pdf | |
| 07/09/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s024lblrpl.pdf | |
| 06/19/2020 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s022lbl.pdf | |
| 06/19/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s022lbl.pdf | |
| 04/02/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s023lbl.pdf | |
| 12/06/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021923s020lbl.pdf | |
| 12/06/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021923s019lbl.pdf | |
| 12/22/2017 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021923s018lbl.pdf | |
| 11/22/2013 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s016lbl.pdf | |
| 10/30/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s015lbl.pdf | |
| 06/11/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s014lbl.pdf | |
| 10/14/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s012lbl.pdf | |
| 10/14/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s012lbl.pdf | |
| 03/22/2011 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s011lbl.pdf | |
| 10/26/2010 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf | |
| 10/26/2010 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf | |
| 11/16/2007 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf | |
| 11/16/2007 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf | |
| 11/16/2007 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf | |
| 11/16/2007 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf | |
| 12/01/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021923lbl.pdf |
NEXAVAR
TABLET;ORAL; EQ 200MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NEXAVAR | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021923 | BAYER HLTHCARE |
| SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 212228 | APOTEX |
| SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 216073 | DR REDDYS |
| SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 207012 | MYLAN |
| SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 209567 | TEVA PHARMS USA INC |
| SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 217095 | TORRENT |
| SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 209050 | YABAO PHARM |