Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205838
Company: UCB INC

• Medication Guide

Products on NDA 205838

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIVIACT	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205838

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 3 - New Dosage Form	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
08/28/2025	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)
05/17/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
09/02/2021	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide	Label (PDF) Letter (PDF)
08/27/2021	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
05/10/2018	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
09/14/2017	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
06/03/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 205838

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
08/28/2025	SUPPL-15	Labeling-Package Insert	Label (PDF)
05/17/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)
05/17/2023	SUPPL-11	Labeling-Medication Guide	Label (PDF)
09/02/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)
09/02/2021	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)
09/02/2021	SUPPL-8	Labeling-Medication Guide	Label (PDF)
08/27/2021	SUPPL-6	Efficacy-New Patient Population	Label (PDF)
05/10/2018	SUPPL-3	Efficacy-New Patient Population	Label (PDF)
09/14/2017	SUPPL-2	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 205838

BRIVIACT

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	219772	ALKEM LABS LTD
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	220164	LUPIN
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	214922	MSN
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	220385	REGCON HOLDINGS
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	218494	ZHEJIANG POLY PHARM
BRIVIACT	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	205838	UCB INC