Application 205838

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIVIACTBRIVARACETAMSOLUTION;ORAL10MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50474-870BriviactbrivaracetamUCB, Inc.NDACurrent
50474-870BriviactbrivaracetamUCB, Inc.NDACurrent
50474-870BriviactbrivaracetamUCB, Inc.NDACurrent
50474-870BriviactbrivaracetamUCB, Inc.NDACurrent
50474-870BriviactbrivaracetamUCB, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83264SUPPL 2025-09-02
83263SUPPL 2025-09-02
83242SUPPL 2025-08-29
74304SUPPL 2023-05-18
74291SUPPL 2023-05-18
69603SUPPL2021-12-16
69602SUPPL2021-12-16
68538SUPPL2021-09-03
68504SUPPL2021-08-31
68503SUPPL2021-08-31
68494SUPPL2021-08-31
54203SUPPL2018-05-16
54184SUPPL2018-05-14
54183SUPPL2018-05-14
49795SUPPL2017-09-19
49738SUPPL2017-09-15
47889ORIG2017-04-07
40517SUPPL2016-06-06
32749SUPPL2016-06-06
43506ORIG2016-03-30
19693ORIG2016-02-19
10516ORIG2016-02-19