APPLICATION
ANDA203370
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-23
LATEST ACTION
2021-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-11-09Labeling · Supplement 13 · standardAP
2021-02-19Labeling · Supplement 12 · standardAP
2019-11-21Labeling · Supplement 9 · standardAP
2019-11-21Labeling · Supplement 7 · standardAP
2017-04-25Labeling · Supplement 2 · standardAP
2017-04-25Labeling · Supplement 3 · standardAP
2013-12-23UNKNOWN · OriginalAP
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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