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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216354
Company: TEVA

Medication Guide

Products on NDA 216354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUSTEDO XR	DEUTETRABENAZINE	6MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
AUSTEDO XR	DEUTETRABENAZINE	12MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
AUSTEDO XR	DEUTETRABENAZINE	24MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
AUSTEDO XR	DEUTETRABENAZINE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
AUSTEDO XR	DEUTETRABENAZINE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
AUSTEDO XR	DEUTETRABENAZINE	42MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
AUSTEDO XR	DEUTETRABENAZINE	48MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
AUSTEDO XR	DEUTETRABENAZINE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216354s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216354Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216354Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-8	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
07/01/2024	SUPPL-7	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216354s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216354Orig1s007ltr.pdf
05/29/2024	SUPPL-6	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216354s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216354Orig1s006ltr.pdf

Labels for NDA 216354

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208082s018,216354s008lbl.pdf
07/01/2024	SUPPL-7	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216354s007lbl.pdf
05/29/2024	SUPPL-6	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216354s006lbl.pdf
02/17/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216354s000lbl.pdf

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