APPLICATION
ANDA200828
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-15
LATEST ACTION
2020-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2020-01-29Labeling · Supplement 7 · standardAP
2020-01-29Labeling · Supplement 6 · standardAP
2020-01-29Labeling · Supplement 4 · standardAP
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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