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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205836
Company: UCB INC

Medication Guide

Products on NDA 205836

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIVIACT	BRIVARACETAM	10MG	TABLET;ORAL	Prescription	AB	Yes	No
BRIVIACT	BRIVARACETAM	25MG	TABLET;ORAL	Prescription	AB	Yes	No
BRIVIACT	BRIVARACETAM	50MG	TABLET;ORAL	Prescription	AB	Yes	No
BRIVIACT	BRIVARACETAM	75MG	TABLET;ORAL	Prescription	AB	Yes	No
BRIVIACT	BRIVARACETAM	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205836

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
02/18/2016	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – May 12, 2016

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/17/2023	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/02/2021	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)
08/27/2021	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
05/10/2018	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
09/14/2017	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
06/03/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 205836

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/17/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)
09/02/2021	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)
09/02/2021	SUPPL-11	Labeling-Medication Guide	Label (PDF)
09/02/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)
08/27/2021	SUPPL-9	Efficacy-New Patient Population	Label (PDF)
05/10/2018	SUPPL-5	Efficacy-New Patient Population	Label (PDF)
09/14/2017	SUPPL-3	Efficacy-New Patient Population	Label (PDF)
06/03/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)
02/18/2016	ORIG-1	Approval	Label (PDF)

Therapeutic Equivalents for NDA 205836

BRIVIACT

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVIACT	BRIVARACETAM	10MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVIACT	BRIVARACETAM	25MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVIACT	BRIVARACETAM	50MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVIACT	BRIVARACETAM	75MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVIACT	BRIVARACETAM	100MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC

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