APPLICATION
ANDA076420
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-21
LATEST ACTION
2016-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET, FOR SUSPENSION · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 5MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2016-09-20Labeling · Supplement 18 · standardAP
2016-09-20Labeling · Supplement 16 · standardAP
2016-09-20Labeling · Supplement 17 · standardAP
2014-09-26Labeling · Supplement 15 · standardAP
2014-09-26Labeling · Supplement 14 · standardAP
2014-09-26Labeling · Supplement 12 · standardAP
2012-04-28Labeling · Supplement 11AP
2012-04-28Labeling · Supplement 9AP
2012-04-28Labeling · Supplement 10AP
2010-11-02Labeling · Supplement 8AP
2010-07-28Labeling · Supplement 6AP
2010-04-28Labeling · Supplement 7AP
2007-10-31Labeling · Supplement 3AP
2007-03-12Labeling · 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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