Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020905
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARAVA | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ARAVA | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| ARAVA | LEFLUNOMIDE | 100MG | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/10/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20905ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/28/2024 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020905s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020905Orig1s033ltr.pdf | |
| 10/18/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020905s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020905Orig1s031ltr.pdf | |
| 11/14/2014 | SUPPL-28 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020905Orig1s028ltr.pdf |
| 08/28/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020905s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020905Orig1s027ltr.pdf | |
| 04/29/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020905s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020905Orig1s025ltr.pdf | |
| 07/08/2011 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020905s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020905s022ltr.pdf | |
| 09/09/2010 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020905s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020905s020ltr.pdf | |
| 04/03/2009 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020905s018ltr.pdf |
| 11/08/2007 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020905s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020905s016ltr.pdf | |
| 10/19/2005 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020905s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020905s015ltr.pdf | |
| 11/22/2004 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905s014ltr.pdf | |
| 03/05/2004 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905se5-012_Arava_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905se5-012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020905_S012_ARAVA.pdf | |
| 06/13/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S007_ARAVA.pdf | |
| 06/13/2003 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S006_ARAVA.pdf | |
| 09/21/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/11/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/28/2024 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020905s033lbl.pdf | |
| 10/18/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020905s031lbl.pdf | |
| 08/28/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020905s027lbl.pdf | |
| 11/02/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020905s025lbl.pdf | |
| 07/08/2011 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020905s022lbl.pdf | |
| 09/09/2010 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020905s020lbl.pdf | |
| 11/08/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020905s016lbl.pdf | |
| 10/19/2005 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020905s015lbl.pdf | |
| 11/22/2004 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905s014lbl.pdf | |
| 03/05/2004 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905se5-012_Arava_lbl.pdf | |
| 06/13/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf | |
| 06/13/2003 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf | |
| 09/10/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf |
ARAVA
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARAVA | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 020905 | SANOFI AVENTIS US |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212453 | ABHAI LLC |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213497 | AET PHARMA |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091369 | ALEMBIC PHARMS LTD |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077090 | APOTEX INC |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213652 | AUROBINDO PHARMA |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077086 | HERITAGE PHARMS |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 211863 | LUPIN LTD |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077087 | WANBANG BIOPHARMS |
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212308 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARAVA | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 020905 | SANOFI AVENTIS US |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212453 | ABHAI LLC |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 213497 | AET PHARMA |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091369 | ALEMBIC PHARMS LTD |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 077090 | APOTEX INC |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 213652 | AUROBINDO PHARMA |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 077086 | HERITAGE PHARMS |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 211863 | LUPIN LTD |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 077087 | WANBANG BIOPHARMS |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212308 | ZYDUS LIFESCIENCES |