Drugs@FDA: FDA Approved Drug Products
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 |
---|---|---|---|---|---|
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-Package Insert, Labeling-Medication Guide |
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-Package Insert, Labeling-Medication Guide |
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 |
---|---|---|---|---|---|
11/29/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s002lbl.pdf | |
11/29/2016 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s002lbl.pdf | |
06/02/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf | |
06/02/2016 | SUPPL-3 | Labeling-Medication Guide | 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 | 209613 | AMNEAL PHARMS CO |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209638 | AUROBINDO PHARMA LTD |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209663 | GLENMARK PHARMS |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209710 | SANDOZ INC |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209700 | TEVA PHARMS USA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209549 | WATSON LABS TEVA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209668 | ZYDUS PHARMS USA INC |
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 | 209613 | AMNEAL PHARMS CO |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209638 | AUROBINDO PHARMA LTD |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209663 | GLENMARK PHARMS |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209710 | SANDOZ INC |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209700 | TEVA PHARMS USA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209549 | WATSON LABS TEVA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209668 | ZYDUS PHARMS USA INC |
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