APPLICATION
ANDA079132
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2022-07-18
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
2022-07-18Labeling · Supplement 27 · standardAP
2022-07-18Labeling · Supplement 28 · standardAP
2019-12-06Labeling · Supplement 23 · standardAP
2019-12-06Labeling · Supplement 20 · standardAP
2016-09-02Labeling · Supplement 13 · standardAP
2016-09-02Labeling · Supplement 16 · standardAP
2016-09-02Labeling · Supplement 14 · standardAP
2014-12-10Labeling · Supplement 11 · standardAP
2014-12-10Labeling · Supplement 7 · standardAP
2014-12-10Labeling · Supplement 12 · standardAP
2014-12-10Labeling · Supplement 8 · standardAP
2010-11-04REMS · Supplement 2AP
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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