APPLICATION
ANDA200672
TYPE
ANDA
ORIGINAL APPROVAL
2013-10-17
LATEST ACTION
2023-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 300MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 250MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-05-19Labeling · Supplement 13 · standardAP
2023-05-19Labeling · Supplement 12 · standardAP
2019-11-21Labeling · Supplement 8 · standardAP
2019-11-21Labeling · Supplement 6 · standardAP
2019-11-21Labeling · Supplement 9 · standardAP
2019-11-21Labeling · Supplement 3 · standardAP
2013-10-17Not Applicable · 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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