Application 021505

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEPPRA	LEVETIRACETAM	SOLUTION;ORAL	100MG/ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-001	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-001	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-001	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-001	Keppra	levetiracetam	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77818	SUPPL	2024-03-13
77798	SUPPL	2024-03-13
77797	SUPPL	2024-03-13
75353	SUPPL	2023-09-05
75340	SUPPL	2023-09-01
75135	SUPPL	2023-08-19
64812	SUPPL	2020-10-02
64811	SUPPL	2020-10-02
64779	SUPPL	2020-10-01
60653	SUPPL	2019-10-24
60646	SUPPL	2019-10-24
60645	SUPPL	2019-10-24
50217	SUPPL	2017-10-30
50175	SUPPL	2017-10-25
48145	SUPPL	2017-04-27
48111	SUPPL	2017-04-25
45765	SUPPL	2016-11-01
45707	SUPPL	2016-10-28
37093	SUPPL	2015-03-12
27962	SUPPL	2015-03-12
5572	SUPPL	2014-08-11
15627	SUPPL	2014-08-08
27961	SUPPL	2014-03-11
37092	SUPPL	2014-03-10
37091	SUPPL	2013-07-30
27960	SUPPL	2013-07-26
27956	SUPPL	2011-12-21
5571	SUPPL	2011-12-21
5570	SUPPL	2011-12-21
5569	SUPPL	2011-12-21
37090	SUPPL	2011-12-20
37087	SUPPL	2011-12-20
15626	SUPPL	2011-12-20
15625	SUPPL	2011-12-20
27959	SUPPL	2011-08-12
37089	SUPPL	2009-05-13
37088	SUPPL	2009-05-13
27958	SUPPL	2009-05-04
27957	SUPPL	2009-05-04
5568	SUPPL	2007-09-25
44130	ORIG	2007-03-28
15624	SUPPL	2007-03-23
5567	SUPPL	2007-03-23
37086	SUPPL	2006-08-18
5566	SUPPL	2006-08-18
27954	SUPPL	2006-01-30
27955	SUPPL	2005-06-23
15623	SUPPL	2005-06-23
21704	ORIG	2004-11-01
27953	SUPPL	2004-10-29
27952	SUPPL	2004-10-29
27951	ORIG	2003-07-28