FDA Approval for AUBAGIO issued to SANOFI AVENTIS US
$SNY
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 202992
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AUBAGIO | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AUBAGIO | TERIFLUNOMIDE | 14MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202992Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2024 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2021 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202992Orig1s013, s015ltr.pdf | |
| 11/06/2020 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202992Orig1s012, s014ltr.pdf | |
| 04/30/2021 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202992Orig1s013, s015ltr.pdf | |
| 11/06/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202992Orig1s012, s014ltr.pdf | |
| 02/28/2020 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202992Orig1s010ltr.pdf | |
| 09/06/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202992s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202992Orig1s008ltr.pdf | |
| 07/24/2019 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202992s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202992Orig1s006ltr.pdf | |
| 12/19/2017 | SUPPL-4 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202992Orig1s004ltr.pdf |
| 06/02/2016 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202992Orig1s003ltr.pdf | |
| 11/29/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202992Orig1s002ltr.pdf | |
| 10/17/2014 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202992s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202992Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf | |
| 04/30/2021 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf | |
| 11/06/2020 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf | |
| 11/06/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf | |
| 02/28/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s010lbl.pdf | |
| 09/06/2019 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202992s008lbl.pdf | |
| 09/06/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202992s008lbl.pdf | |
| 07/24/2019 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202992s006lbl.pdf | |
| 11/29/2016 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s002lbl.pdf | |
| 11/29/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s002lbl.pdf | |
| 06/02/2016 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf | |
| 06/02/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf | |
| 10/17/2014 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202992s001lbl.pdf | |
| 09/12/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf |
AUBAGIO
TABLET;ORAL; 7MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AUBAGIO | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | Yes | AB | 202992 | SANOFI AVENTIS US |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209690 | ACCORD HLTHCARE |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209572 | ALEMBIC |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209613 | AMNEAL PHARMS CO |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209601 | APOTEX |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209638 | AUROBINDO PHARMA |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209639 | BIOCON PHARMA |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209663 | GLENMARK PHARMS |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209598 | HETERO LABS LTD V |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209623 | MSN |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209555 | NATCO |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209710 | SANDOZ |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209677 | SOLA PHARMS |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209700 | TEVA PHARMS USA |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209697 | TORRENT |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209668 | ZYDUS PHARMS |
TABLET;ORAL; 14MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AUBAGIO | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | Yes | AB | 202992 | SANOFI AVENTIS US |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209690 | ACCORD HLTHCARE |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209572 | ALEMBIC |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209613 | AMNEAL PHARMS CO |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209601 | APOTEX |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209638 | AUROBINDO PHARMA |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209639 | BIOCON PHARMA |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209663 | GLENMARK PHARMS |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209598 | HETERO LABS LTD V |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209623 | MSN |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209555 | NATCO |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209710 | SANDOZ |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209677 | SOLA PHARMS |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209700 | TEVA PHARMS USA |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209697 | TORRENT |
| TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209668 | ZYDUS PHARMS |