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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208082
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUSTEDO DEUTETRABENAZINE 6MG TABLET;ORAL Prescription None Yes No
AUSTEDO DEUTETRABENAZINE 9MG TABLET;ORAL Prescription None Yes No
AUSTEDO DEUTETRABENAZINE 12MG 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
04/03/2017 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208082Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/04/2022 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208082s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208082Orig1s011ltr.pdf
06/24/2021 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208082s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208082Orig1s009ltr.pdf
02/09/2021 SUPPL-8 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208082Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208082Orig1s008ltr.pdf
12/02/2020 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208082s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208082Orig1s007ltr.pdf
07/15/2019 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208082s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208082Orig1s004ltr.pdf
06/06/2018 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208082s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208082Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2022 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208082s011lbl.pdf
05/04/2022 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208082s011lbl.pdf
06/24/2021 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208082s009lbl.pdf
02/09/2021 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208082Orig1s008lbl.pdf
12/02/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208082s007lbl.pdf
07/15/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208082s004lbl.pdf
06/06/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208082s002lbl.pdf
06/06/2018 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208082s002lbl.pdf
04/03/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
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