Application 022253

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIMPAT	LACOSAMIDE	TABLET;ORAL	50MG	Yes	No
002	VIMPAT	LACOSAMIDE	TABLET;ORAL	100MG	Yes	No
003	VIMPAT	LACOSAMIDE	TABLET;ORAL	150MG	Yes	No
004	VIMPAT	LACOSAMIDE	TABLET;ORAL	200MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75869	SUPPL	2023-10-20
75868	SUPPL	2023-10-20
75858	SUPPL	2023-10-17
74135	SUPPL	2023-05-01
74129	SUPPL	2023-05-01
72230	SUPPL	2022-10-03
72229	SUPPL	2022-10-03
72205	SUPPL	2022-10-03
71118	SUPPL	2022-05-20
71117	SUPPL	2022-05-20
71113	SUPPL	2022-05-20
69025	SUPPL	2021-10-19
69003	SUPPL	2021-10-15
69002	SUPPL	2021-10-15
68647	SUPPL	2021-09-20
68646	SUPPL	2021-09-20
68636	SUPPL	2021-09-17
65255	SUPPL	2020-11-17
65254	SUPPL	2020-11-17
65238	SUPPL	2020-11-16
65237	SUPPL	2020-11-16
65236	SUPPL	2020-11-16
65235	SUPPL	2020-11-16
59042	SUPPL	2019-06-12
59023	SUPPL	2019-06-12
59022	SUPPL	2019-06-12
57569	SUPPL	2019-02-13
57162	SUPPL	2019-01-10
56677	SUPPL	2018-12-07
56442	SUPPL	2018-11-23
50325	SUPPL	2017-11-07
47751	SUPPL	2017-03-29
47708	SUPPL	2017-03-27
17141	SUPPL	2015-07-13
7107	SUPPL	2015-07-13
38437	SUPPL	2014-09-03
29462	SUPPL	2014-09-03
29461	SUPPL	2014-09-03
17140	SUPPL	2014-09-03
38438	SUPPL	2014-08-19
7106	SUPPL	2014-08-14
38435	SUPPL	2014-01-17
29460	SUPPL	2014-01-17
38434	SUPPL	2013-09-27
17138	SUPPL	2013-09-27
29457	SUPPL	2013-09-26
7104	SUPPL	2013-09-26
7105	SUPPL	2013-04-23
38436	SUPPL	2013-04-19
38433	SUPPL	2013-02-12
7103	SUPPL	2013-02-12
29459	SUPPL	2013-02-07
17139	SUPPL	2013-02-06
17137	SUPPL	2012-08-28
29458	SUPPL	2011-08-12
7102	SUPPL	2010-05-04
7101	SUPPL	2010-01-20
38432	SUPPL	2009-11-20
44716	ORIG	2008-12-17
21971	ORIG	2008-12-17
7100	ORIG	2008-10-31
17136	ORIG	2008-10-29
63109	SUPPL	1900-01-01
63108	SUPPL	1900-01-01
63107	SUPPL	1900-01-01

Application 022253

Related Records#

Application Products#

NDC Listings For This Application#

Documents#