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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209241
Company: NEUROCRINE

Summary Review

Products on NDA 209241

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INGREZZA	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
INGREZZA	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	Yes
INGREZZA	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209241

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209241Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-26	Efficacy	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209241Orig1s026ltr.pdf
08/11/2022	SUPPL-24		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209241Orig1s024lbl.pdf
04/23/2021	SUPPL-20	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209241Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209241Orig1s020ltr.pdf
04/09/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209241s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209241Orig1s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/209241Orig1s016.pdf
07/15/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209241s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209241Orig1s012Replacementltr.pdf
01/10/2019	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
08/10/2018	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209241s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209241Orig1s003ltr.pdf

Labels for NDA 209241

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-26	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s026lbl.pdf
08/11/2022	SUPPL-24	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209241Orig1s024lbl.pdf
04/23/2021	SUPPL-20	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209241Orig1s020lbl.pdf
04/09/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209241s016lbl.pdf
07/15/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209241s012lbl.pdf
08/10/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209241s003lbl.pdf
04/11/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf

Therapeutic Equivalents for NDA 209241

INGREZZA

CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INGREZZA	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	209241	NEUROCRINE
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	216064	LUPIN LTD
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	216137	ZYDUS

CAPSULE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INGREZZA	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	209241	NEUROCRINE
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	No	AB	216064	LUPIN LTD
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	No	AB	216137	ZYDUS

CAPSULE;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INGREZZA	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	209241	NEUROCRINE
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE;ORAL	Prescription	No	AB	216137	ZYDUS

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