FDA.reportPublic FDA data

Application 022254

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIMPATLACOSAMIDESOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent
0131-1810VimpatlacosamideUCB, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75871SUPPL 2023-10-20
75870SUPPL 2023-10-20
75829SUPPL 2023-10-17
74137SUPPL 2023-05-01
74130SUPPL 2023-05-01
72232SUPPL2022-10-03
72231SUPPL2022-10-03
72206SUPPL2022-10-03
71116SUPPL2022-05-20
71112SUPPL2022-05-20
69026SUPPL2021-10-19
69005SUPPL2021-10-15
69004SUPPL2021-10-15
68649SUPPL2021-09-20
68648SUPPL2021-09-20
68637SUPPL2021-09-17
65257SUPPL2020-11-17
65256SUPPL2020-11-17
65242SUPPL2020-11-16
65241SUPPL2020-11-16
65240SUPPL2020-11-16
65239SUPPL2020-11-16
59044SUPPL2019-06-12
59024SUPPL2019-06-12
59021SUPPL2019-06-12
57570SUPPL2019-02-13
57163SUPPL2019-01-10
56678SUPPL2018-12-07
56438SUPPL2018-11-23
50327SUPPL2017-11-07
47750SUPPL2017-03-29
47706SUPPL2017-03-27
38446SUPPL2015-07-13
29473SUPPL2015-07-13
38445SUPPL2014-09-03
29472SUPPL2014-09-03
29471SUPPL2014-09-03
17145SUPPL2014-09-03
7110SUPPL2014-08-14
17146SUPPL2014-08-13
38443SUPPL2014-01-17
7109SUPPL2014-01-17
38442SUPPL2013-09-27
17143SUPPL2013-09-27
29467SUPPL2013-09-26
7108SUPPL2013-09-26
29470SUPPL2013-04-23
38444SUPPL2013-04-19
38441SUPPL2013-02-12
29466SUPPL2013-02-12
29469SUPPL2013-02-07
17144SUPPL2013-02-06
38440SUPPL2012-08-28
29468SUPPL2011-08-12
29465SUPPL2010-05-04
29464SUPPL2010-01-20
17142SUPPL2009-11-20
42467ORIG2008-12-17
24266ORIG2008-12-17
29463ORIG2008-10-31
38439ORIG2008-10-29