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FDA ANDA · ANDA201168
LAMOTRIGINE
lamotrigine chewable dispersible
Sponsor: ALEMBIC
APPLICATION
ANDA201168
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-12
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 5MG · TABLET, FOR SUSPENSION · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2026-01-30Labeling · Supplement 21 · standardAP
2026-01-30Labeling · Supplement 18 · standardAP
2026-01-30Labeling · Supplement 29 · standardAP
2026-01-30Labeling · Supplement 27 · standardAP
2026-01-30Labeling · Supplement 19 · standardAP
2019-12-17Labeling · Supplement 7 · standardAP
2019-12-17Labeling · Supplement 13 · standardAP
2019-12-17Labeling · Supplement 14 · standardAP
2017-12-29Labeling · Supplement 3 · standardAP
2017-12-29Labeling · Supplement 1 · standardAP
2017-12-29Labeling · Supplement 4 · standardAP
2014-06-12Not 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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