UCB INC FDA Approval NDA 022254

Application #022254

Documents

Letter	2013-09-26
Letter	2014-01-17
Letter	2014-08-14
Label	2009-11-20
Label	2013-09-27
Label	2013-02-06
Label	2014-09-03
Label	2014-08-13
Summary Review	2008-12-17
Letter	2008-10-31
Letter	2010-01-20
Letter	2010-05-04
Letter	2013-02-12
Letter	2013-09-26
Letter	2011-08-12
Letter	2013-02-07
Letter	2013-04-23
Letter	2014-09-03
Letter	2014-09-03
Letter	2015-07-13
Label	2008-10-29
Label	2012-08-28
Label	2013-02-12
Label	2013-09-27
Label	2014-01-17
Label	2013-04-19
Label	2014-09-03
Label	2015-07-13
Review	2008-12-17
Label	2017-03-27
Letter	2017-03-29
Label	2017-11-07
Label	2018-11-23
Letter	2018-12-07
Label	2019-01-10
Letter	2019-02-13
Label	2019-06-12
Medication Guide	2019-06-12
Letter	2019-06-12
Label	2020-11-16
Medication Guide	2020-11-16
Label	2020-11-16
Medication Guide	2020-11-16
Letter	2020-11-17
Letter	2020-11-17
Letter	2021-09-17
Label	2021-09-20
Medication Guide	2021-09-20
Label	2021-10-15
Medication Guide	2021-10-15
Letter	2021-10-19
Letter	2022-05-20
Label	2022-05-20
Letter	2022-10-03
Label	2022-10-03
Medication Guide	2022-10-03

Application Sponsors

NDA 022254

UCB INC

Marketing Status

Prescription

001

Application Products

001

SOLUTION;INTRAVENOUS

200MG/20ML (10MG/ML)

VIMPAT

LACOSAMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2008-10-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2010-04-20	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2013-02-08	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2013-09-25	STANDARD
LABELING; Labeling	SUPPL	9	AP	2013-09-25	UNKNOWN
REMS; REMS	SUPPL	13	AP	2011-08-10	N/A
LABELING; Labeling	SUPPL	14	AP	2013-02-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2014-01-16	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2016-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-10-02	STANDARD
LABELING; Labeling	SUPPL	18	AP	2013-04-17	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2014-08-29	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2014-08-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2014-08-12	STANDARD
LABELING; Labeling	SUPPL	22	AP	2015-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2016-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2016-11-02	STANDARD
LABELING; Labeling	SUPPL	29	AP	2017-03-24	STANDARD
EFFICACY; Efficacy	SUPPL	30	AP	2017-11-03	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2019-01-09	STANDARD
LABELING; Labeling	SUPPL	33	AP	2018-11-11	STANDARD
LABELING; Labeling	SUPPL	35	AP	2019-06-11	STANDARD
EFFICACY; Efficacy	SUPPL	36	AP	2020-11-16	STANDARD
EFFICACY; Efficacy	SUPPL	38	AP	2020-11-16	STANDARD
EFFICACY; Efficacy	SUPPL	39	AP	2021-10-14	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-09-15	STANDARD
LABELING; Labeling	SUPPL	44	AP	2022-05-19	STANDARD
LABELING; Labeling	SUPPL	45	AP	2022-09-30	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6
SUPPL	5	Null	6
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	6
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	6
SUPPL	21	Null	7
SUPPL	22	Null	7
SUPPL	26	Null	0
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	32	Null	7
SUPPL	33	Null	31
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	38	Null	7
SUPPL	39	Null	15
SUPPL	41	Null	6
SUPPL	44	Null	4
SUPPL	45	Null	7

TE Codes

001

Prescription

CDER Filings

UCB INC

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            [supplements] => 
            [actionDate] => 2019-06-11
        )

)

NDA 022254

UCB INC

FDA Drug Application

Application #022254

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

UCB INC