APPLICATION
ANDA078134
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-19
LATEST ACTION
2022-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 100MG · TABLET · ORAL
Approval history
2022-06-15Labeling · Supplement 11 · standardAP
2022-06-15Labeling · Supplement 10 · standardAP
2019-11-21Labeling · Supplement 9 · standardAP
2019-11-21Labeling · Supplement 8 · standardAP
2014-12-14Labeling · Supplement 7 · standardAP
2014-12-14Labeling · Supplement 5 · standardAP
2014-12-14Labeling · Supplement 6 · standardAP
2012-05-17Labeling · Supplement 4AP
2011-09-29Labeling · Supplement 2AP
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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