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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202992
Company: SANOFI AVENTIS US

Medication Guide

Summary Review

Products on NDA 202992

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202992

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
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

Labels for NDA 202992

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

Therapeutic Equivalents for NDA 202992

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

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