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FDA ANDA · ANDA076928

LAMOTRIGINE

Sponsor: WATSON LABS

APPLICATION
ANDA076928
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-22
LATEST ACTION
2020-01-30
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
LAMOTRIGINEPrescription
LAMOTRIGINE 2MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2020-01-30Labeling · Supplement 16 · standardAP
2020-01-30Labeling · Supplement 15 · standardAP
2014-09-26Labeling · Supplement 14 · standardAP
2012-05-18Labeling · Supplement 9AP
2011-09-29Labeling · Supplement 6AP
2009-09-21Labeling · Supplement 3AP
2009-09-21Labeling · Supplement 1AP
2009-01-22Original — 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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