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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205837
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRIVIACT BRIVARACETAM 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
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
09/02/2021 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
08/27/2021 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
05/10/2018 SUPPL-4 Labeling-Package Insert 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)
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
09/02/2021 SUPPL-9 Labeling-Medication Guide Label (PDF)
09/02/2021 SUPPL-9 Labeling-Package Insert Label (PDF)
09/02/2021 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
08/27/2021 SUPPL-7 Efficacy-New Patient Population Label (PDF)
05/10/2018 SUPPL-4 Labeling-Package Insert 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)
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