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FDA ANDA · ANDA214124

LAMOTRIGINE

Sponsor: J MOLNER

APPLICATION
ANDA214124
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-03
LATEST ACTION
2022-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2022-02-03UNKNOWN · Original · standardAP
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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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