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FDA NDA · NDA022255

VIMPAT

lacosamide

Sponsor: UCB INC

APPLICATION
NDA022255
TYPE
NDA
ORIGINAL APPROVAL
2010-04-20
LATEST ACTION
2023-10-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VIMPAT · ReferencePrescription
LACOSAMIDE 10MG/ML · SOLUTION · ORAL

Approval history

2023-10-16Labeling · Supplement 39 · standard — Letter ↗AP
2023-04-28Efficacy · Supplement 32 · standard — Letter ↗AP
2022-09-30Labeling · Supplement 37 · standard — Letter ↗AP
2022-05-19Labeling · Supplement 36 · standard — Letter ↗AP
2021-10-14Efficacy · Supplement 31 · standard — Label ↗AP
2021-09-15Labeling · Supplement 33 · standard — Letter ↗AP
2020-11-16Efficacy · Supplement 30 · standard — Label ↗AP
2020-11-16Efficacy · Supplement 27 · standard — Label ↗AP
2019-06-11Labeling · Supplement 26 · standard — Label ↗AP
2019-01-09Efficacy · Supplement 23 · standard — Label ↗AP
2018-11-11Labeling · Supplement 24 · standard — Label ↗AP
2017-11-03Efficacy · Supplement 22 · standard — Label ↗AP
2017-03-24Labeling · Supplement 21 · standard — Label ↗AP
2016-02-26Manufacturing (CMC) · Supplement 17 · standardAP
2015-07-09Labeling · Supplement 16 · standard — Letter ↗AP
2014-08-29Efficacy · Supplement 12 · standard — Label ↗AP
2014-08-29Efficacy · Supplement 13 · standard — Label ↗AP
2014-08-12Labeling · Supplement 14 · standard — Letter ↗AP
2014-04-11Manufacturing (CMC) · Supplement 15 · standardAP
2014-01-17Manufacturing (CMC) · Supplement 11 · standardAP
2014-01-16Labeling · Supplement 9 · unknown — Label ↗AP
2013-09-25Labeling · Supplement 5 · standard — Label ↗AP
2013-09-25Labeling · Supplement 3 · standard — Label ↗AP
2013-04-17Labeling · Supplement 10 · standard — Letter ↗AP
2013-02-08Labeling · Supplement 2 · standard — Letter ↗AP
2013-02-05Labeling · Supplement 8 · standard — Letter ↗AP
2011-08-10REMS · Supplement 7 — Letter ↗AP
2010-04-20Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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