APPLICATION
ANDA200694
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-14
LATEST ACTION
2024-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
Approval history
2024-10-09Labeling · Supplement 4 · standardAP
2019-12-06Labeling · Supplement 3 · standardAP
2019-12-06Labeling · Supplement 1 · standardAP
2013-06-14Not 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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