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FDA ANDA · ANDA078443

LAMOTRIGINE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA078443
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-11
LATEST ACTION
2022-06-23
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

2022-06-23Labeling · Supplement 2 · standardAP
2016-01-12Labeling · Supplement 1AP
2009-02-11OriginalOther Important Information from FDAAP
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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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