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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020905
Company: SANOFI AVENTIS US

Products on NDA 020905

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020905

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
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.

Labels for NDA 020905

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

Therapeutic Equivalents for NDA 020905

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

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