NDA 021035

UCB INC

FDA Drug Application

Application #021035

Documents

• Letter: 1999-11-30
• Letter: 2002-05-22
• Letter: 2002-05-22
• Letter: 2003-09-09
• Letter: 2004-10-29
• Letter: 2004-10-29
• Letter: 2006-01-30
• Letter: 2005-06-23
• Letter: 2006-08-18
• Letter: 2007-09-25
• Letter: 2011-12-21
• Letter: 2009-05-04
• Letter: 2009-05-04
• Letter: 2011-12-21
• Letter: 2013-07-26
• Letter: 2014-03-11
• Label: 1999-11-30
• Label: 2006-08-18
• Label: 2007-03-23
• Label: 2011-12-20
• Label: 2009-05-13
• Label: 2009-05-13
• Label: 2011-12-20
• Label: 2013-07-30
• Label: 2014-03-10
• Label: 2015-03-12
• Other Important Information from FDA: 2007-03-28
• Letter: 2006-01-20
• Letter: 2011-12-21
• Letter: 2006-08-18
• Letter: 2007-03-23
• Letter: 2011-12-21
• Letter: 2011-12-21
• Letter: 2011-08-12
• Letter: 2015-03-12
• Letter: 2014-08-11
• Label: 2005-06-23
• Label: 2011-12-20
• Label: 2006-08-18
• Label: 2011-12-20
• Label: 2011-12-20
• Label: 2014-08-08
• Review: 1999-11-30
• Letter: 2016-10-28
• Label: 2016-11-01
• Label: 2017-04-25
• Letter: 2017-04-27
• Label: 2017-10-27
• Letter: 2017-10-30
• Pediatric Medical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 2008-06-03
• Pediatric Amendment 1: 2008-06-03
• Pediatric Reissue Amendment 1: 2008-06-03
• Pediatric Reissue Amendment 2: 2008-06-03
• Pediatric Amendment 2: 2008-06-03
• Pediatric Reissue Amendment 3: 2008-06-03
• Pediatric Medical Review: 2008-06-03
• Pediatric Clinical Pharmacology Review: 2008-06-03
• Pediatric Clinical Pharmacology Addendum: 2008-06-03
• Label: 2019-10-24
• Medication Guide: 2019-10-24
• Letter: 2019-10-24
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Amendment 2: 1900-01-01
• Pediatric Amendment 3: 1900-01-01
• Pediatric Reissue Amendment 1: 1900-01-01
• Pediatric Reissue Amendment 2: 1900-01-01
• Letter: 2020-10-01
• Label: 2020-10-02
• Medication Guide: 2020-10-02
• Review: 2022-10-19

Application Sponsors

NDA 021035

UCB INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	250MG	1	KEPPRA	LEVETIRACETAM
002	TABLET;ORAL	500MG	1	KEPPRA	LEVETIRACETAM
003	TABLET;ORAL	750MG	1	KEPPRA	LEVETIRACETAM
004	TABLET;ORAL	1GM	1	KEPPRA	LEVETIRACETAM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-11-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-07-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-11-27	STANDARD
LABELING; Labeling	SUPPL	13	AP	2002-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-05-07	STANDARD
LABELING; Labeling	SUPPL	19	AP	2002-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-10-17	STANDARD
LABELING; Labeling	SUPPL	30	AP	2003-09-03	STANDARD
LABELING; Labeling	SUPPL	32	AP	2004-10-26	STANDARD
LABELING; Labeling	SUPPL	33	AP	2004-10-26	STANDARD
LABELING; Labeling	SUPPL	38	AP	2006-01-24	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2005-06-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2006-01-06	STANDARD
EFFICACY; Efficacy	SUPPL	50	AP	2006-08-15	UNKNOWN
LABELING; Labeling	SUPPL	52	AP	2011-12-16	STANDARD
LABELING; Labeling	SUPPL	54	AP	2006-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2006-08-16	N/A
EFFICACY; Efficacy	SUPPL	57	AP	2007-03-19	STANDARD
LABELING; Labeling	SUPPL	62	AP	2007-09-12	STANDARD
EFFICACY; Efficacy	SUPPL	73	AP	2011-12-16	PRIORITY
LABELING; Labeling	SUPPL	74	AP	2011-12-16	STANDARD
LABELING; Labeling	SUPPL	78	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	79	AP	2009-04-23	STANDARD
LABELING; Labeling	SUPPL	80	AP	2009-04-23	STANDARD
LABELING; Labeling	SUPPL	83	AP	2011-12-16	STANDARD
LABELING; Labeling	SUPPL	85	AP	2011-12-16	STANDARD
LABELING; Labeling	SUPPL	89	AP	2013-07-25	STANDARD
REMS; REMS	SUPPL	90	AP	2011-08-10	N/A
LABELING; Labeling	SUPPL	91	AP	2014-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	92	AP	2012-11-13	STANDARD
LABELING; Labeling	SUPPL	93	AP	2015-03-10	STANDARD
LABELING; Labeling	SUPPL	94	AP	2014-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	2016-02-04	STANDARD
LABELING; Labeling	SUPPL	96	AP	2016-10-26	STANDARD
LABELING; Labeling	SUPPL	99	AP	2017-04-24	STANDARD
LABELING; Labeling	SUPPL	100	AP	2017-10-24	STANDARD
EFFICACY; Efficacy	SUPPL	102	AP	2019-10-23	STANDARD
LABELING; Labeling	SUPPL	104	AP	2020-09-30	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	48	Null	0
SUPPL	52	Null	6
SUPPL	73	Null	7
SUPPL	74	Null	7
SUPPL	80	Null	7
SUPPL	83	Null	7
SUPPL	85	Null	7
SUPPL	89	Null	15
SUPPL	90	Null	6
SUPPL	91	Null	6
SUPPL	92	Null	0
SUPPL	93	Null	15
SUPPL	94	Null	6
SUPPL	95	Null	0
SUPPL	96	Null	15
SUPPL	99	Null	7
SUPPL	100	Null	15
SUPPL	102	Null	15
SUPPL	104	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

UCB INC

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(
    [0] => Array
        (
            [ApplNo] => 21035
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021035s102,021505s042lbl.pdf#page=32"]
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(PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-80","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-78","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021035s078s080,021505s021s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2007","submission":"SUPPL-57","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021035s057,021505s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2006","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"KEPPRA","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KEPPRA","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KEPPRA","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KEPPRA","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-23
        )

)