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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208082
Company: TEVA BRANDED PHARM

Medication Guide

Products on NDA 208082

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUSTEDO	DEUTETRABENAZINE	6MG	TABLET;ORAL	Prescription	AB	Yes	No
AUSTEDO	DEUTETRABENAZINE	9MG	TABLET;ORAL	Prescription	AB	Yes	No
AUSTEDO	DEUTETRABENAZINE	12MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208082

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208082s018,216354s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208082Orig1s018,216354Orig1s008correctedltr.pdf
11/26/2024	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208082Orig1s016;s017ltr.pdf
11/26/2024	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208082Orig1s016;s017ltr.pdf
09/28/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208082s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208082Orig1s014ltr.pdf
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-Medication Guide, Labeling-Package Insert	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

Labels for NDA 208082

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208082s018,216354s008lbl.pdf
11/26/2024	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s016s017lbl.pdf
11/26/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s016s017lbl.pdf
09/28/2023	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208082s014lbl.pdf
09/28/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208082s014lbl.pdf
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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208082s002lbl.pdf
06/06/2018	SUPPL-2	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 208082

AUSTEDO

TABLET;ORAL; 6MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUSTEDO	DEUTETRABENAZINE	6MG	TABLET;ORAL	Prescription	Yes	AB	208082	TEVA BRANDED PHARM

TABLET;ORAL; 9MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUSTEDO	DEUTETRABENAZINE	9MG	TABLET;ORAL	Prescription	Yes	AB	208082	TEVA BRANDED PHARM

TABLET;ORAL; 12MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUSTEDO	DEUTETRABENAZINE	12MG	TABLET;ORAL	Prescription	Yes	AB	208082	TEVA BRANDED PHARM

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