APPLICATION
ANDA076708
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2016-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
Approval history
2016-09-26Labeling · Supplement 8 · standardAP
2014-09-26Labeling · Supplement 7 · standardAP
2012-03-15Labeling · Supplement 6AP
2012-03-15Labeling · Supplement 5AP
2011-09-29Labeling · Supplement 4AP
2010-02-24Labeling · Supplement 3AP
2009-09-21Labeling · Supplement 2AP
2009-09-21Labeling · Supplement 1AP
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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