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FDA ANDA · ANDA079099

LAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA079099
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-19
LATEST ACTION
2026-04-17
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

2026-04-17Labeling · Supplement 23 · standardAP
2026-04-17Labeling · Supplement 21 · standardAP
2024-04-11Labeling · Supplement 16 · standardAP
2024-04-11Labeling · Supplement 15 · standardAP
2020-02-10Labeling · Supplement 8 · standardAP
2020-02-10Labeling · Supplement 14 · standardAP
2020-02-10Labeling · Supplement 12 · standardAP
2020-02-10Labeling · Supplement 10 · standardAP
2020-02-10Labeling · Supplement 9 · standardAP
2020-02-10Labeling · Supplement 7 · standardAP
2020-02-10Labeling · Supplement 13 · standardAP
2020-02-10Labeling · Supplement 11 · standardAP
2014-12-08Labeling · Supplement 6 · standardAP
2012-05-31Labeling · Supplement 5 · standardAP
2012-03-26Labeling · Supplement 4AP
2010-07-28Labeling · Supplement 1AP
2009-02-19Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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