APPLICATION
ANDA076388
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-30
LATEST ACTION
2016-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET · ORAL
Approval history
2016-09-30Labeling · Supplement 28 · standardAP
2016-09-30Labeling · Supplement 26 · standardAP
2016-09-30Labeling · Supplement 27 · standardAP
2014-09-26Labeling · Supplement 24 · standardAP
2014-09-26Labeling · Supplement 23 · standardAP
2014-09-26Labeling · Supplement 21 · standardAP
2012-04-30Labeling · Supplement 20AP
2012-04-30Labeling · Supplement 19AP
2011-09-29Labeling · Supplement 17AP
2010-04-28Labeling · Supplement 14AP
2010-04-28Labeling · Supplement 13AP
2009-12-20Labeling · Supplement 12AP
2008-03-14Labeling · Supplement 6AP
2007-10-31Labeling · Supplement 1AP
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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