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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205836
Company: UCB INC
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
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
09/02/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels 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)
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
09/02/2021 SUPPL-11 Labeling-Medication Guide Label (PDF)
09/02/2021 SUPPL-11 Labeling-Package Insert Label (PDF)
09/02/2021 SUPPL-11 Labeling-Container/Carton Labels 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)

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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