FDA.reportPublic FDA data

Application 205837

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIVIACTBRIVARACETAMSOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50474-970BriviactbrivaracetamUCB, Inc.NDACurrent
50474-970BriviactbrivaracetamUCB, Inc.NDACurrent
50474-970BriviactbrivaracetamUCB, Inc.NDACurrent
50474-970BriviactbrivaracetamUCB, Inc.NDACurrent
50474-970BriviactbrivaracetamUCB, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83262SUPPL 2025-09-02
83261SUPPL 2025-09-02
83241SUPPL 2025-08-29
74303SUPPL 2023-05-18
74289SUPPL 2023-05-18
69604SUPPL2021-12-16
69601SUPPL2021-12-16
68537SUPPL2021-09-03
68502SUPPL2021-08-31
68501SUPPL2021-08-31
68493SUPPL2021-08-31
54202SUPPL2018-05-16
54185SUPPL2018-05-14
54182SUPPL2018-05-14
49794SUPPL2017-09-19
49740SUPPL2017-09-15
47888ORIG2017-04-07
40516SUPPL2016-06-06
32748SUPPL2016-06-06
43505ORIG2016-03-30
19692ORIG2016-02-19
10515ORIG2016-02-19