Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202992
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
09/06/2019 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide 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-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
09/06/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202992s008lbl.pdf
09/06/2019 SUPPL-8 Labeling-Medication Guide 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

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 PHARMS LTD
TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET;ORAL Prescription No AB 209663 GLENMARK PHARMS
TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET;ORAL Prescription No AB 209710 SANDOZ 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 209572 ALEMBIC PHARMS LTD
TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET;ORAL Prescription No AB 209663 GLENMARK PHARMS
TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET;ORAL Prescription No AB 209710 SANDOZ INC

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