Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020905
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)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20905ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20905_arava.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
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 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077083 BARR
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077084 TEVA PHARMS

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 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077083 BARR
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077084 TEVA PHARMS

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