FDA.reportPublic FDA data

Application 022255

Type
NDA
Sponsor
UCB INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
0131-5410VimpatlacosamideUCB, Inc.NDACurrent
66689-107LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-107LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-108LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-108LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-109LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-109LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-110LacosamideLacosamideVistaPharm, Inc.NDACurrent
66689-110LacosamideLacosamideVistaPharm, Inc.NDACurrent
70166-617VimpatlacosamideLohxaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75873SUPPL 2023-10-20
75872SUPPL 2023-10-20
75830SUPPL 2023-10-17
74139SUPPL 2023-05-01
74131SUPPL 2023-05-01
72234SUPPL2022-10-03
72233SUPPL2022-10-03
72207SUPPL2022-10-03
71119SUPPL2022-05-20
71114SUPPL2022-05-20
69027SUPPL2021-10-19
69007SUPPL2021-10-15
69006SUPPL2021-10-15
68651SUPPL2021-09-20
68650SUPPL2021-09-20
68638SUPPL2021-09-17
65259SUPPL2020-11-17
65258SUPPL2020-11-17
65246SUPPL2020-11-16
65245SUPPL2020-11-16
65244SUPPL2020-11-16
65243SUPPL2020-11-16
59043SUPPL2019-06-12
59025SUPPL2019-06-12
59020SUPPL2019-06-12
57571SUPPL2019-02-13
57164SUPPL2019-01-10
56679SUPPL2018-12-07
56440SUPPL2018-11-23
50329SUPPL2017-11-07
47749SUPPL2017-03-29
47704SUPPL2017-03-27
17154SUPPL2015-07-13
7118SUPPL2015-07-13
38449SUPPL2014-09-03
29477SUPPL2014-09-03
29476SUPPL2014-09-03
17152SUPPL2014-09-03
7117SUPPL2014-08-14
17153SUPPL2014-08-13
38448SUPPL2014-01-17
7115SUPPL2014-01-17
38447SUPPL2013-09-27
17149SUPPL2013-09-27
29474SUPPL2013-09-26
7113SUPPL2013-09-26
7116SUPPL2013-04-23
17151SUPPL2013-04-19
17148SUPPL2013-02-12
7112SUPPL2013-02-12
7114SUPPL2013-02-07
17150SUPPL2013-02-06
17147ORIG2012-08-28
29475SUPPL2011-08-12
44717ORIG2011-02-17
42468ORIG2010-12-01
7111ORIG2010-05-04