Application 021872

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEPPRA	LEVETIRACETAM	INJECTABLE;INTRAVENOUS	500MG/5ML (100MG/ML)	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-002	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-002	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-002	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-002	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-002	Keppra	levetiracetam	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77820	SUPPL	2024-03-13
77794	SUPPL	2024-03-13
75139	SUPPL	2023-08-18
75119	SUPPL	2023-08-18
64810	SUPPL	2020-10-02
64781	SUPPL	2020-10-01
60654	SUPPL	2019-10-24
60647	SUPPL	2019-10-24
50218	SUPPL	2017-10-30
50174	SUPPL	2017-10-25
48144	SUPPL	2017-04-27
48112	SUPPL	2017-04-25
45764	SUPPL	2016-11-01
45708	SUPPL	2016-10-28
16496	SUPPL	2016-04-27
28749	SUPPL	2016-04-25
37799	SUPPL	2015-03-12
28748	SUPPL	2015-03-12
16495	SUPPL	2014-11-04
6353	SUPPL	2014-11-03
6354	SUPPL	2014-08-11
37800	SUPPL	2014-08-08
6352	SUPPL	2014-03-11
16494	SUPPL	2014-03-10
37798	SUPPL	2013-07-30
16493	SUPPL	2013-07-30
6351	SUPPL	2013-07-26
6350	SUPPL	2013-07-26
16492	SUPPL	2012-12-07
6349	SUPPL	2008-05-21
21850	ORIG	2008-02-22
28747	SUPPL	2007-09-25
6348	SUPPL	2007-09-25
37797	SUPPL	2007-09-19
16491	SUPPL	2007-09-19
23681	ORIG	2007-03-28
37796	ORIG	2006-08-04
68835	SUPPL	1900-01-01
68834	SUPPL	1900-01-01
67200	ORIG	1900-01-01
67199	ORIG	1900-01-01