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FDA ANDA · ANDA077783

LAMOTRIGINE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA077783
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-01
LATEST ACTION
2018-10-23
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

2018-10-23Labeling · Supplement 14 · standardAP
2018-10-23Labeling · Supplement 13 · standardAP
2016-09-20Labeling · Supplement 6 · standardAP
2016-09-20Labeling · Supplement 9 · standardAP
2016-09-20Labeling · Supplement 7 · standardAP
2016-09-20Labeling · Supplement 3 · standardAP
2010-11-01OriginalAP
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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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