Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020764


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NDA 020764 describes LAMICTAL CD, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the LAMICTAL CD profile page.

The generic ingredient in LAMICTAL CD is lamotrigine. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 020764
Tradename:LAMICTAL CD
Applicant:Glaxosmithkline Llc
Ingredient:lamotrigine
Patents:0
Pharmacology for NDA: 020764
Mechanism of ActionDihydrofolate Reductase Inhibitors
Organic Cation Transporter 2 Inhibitors
Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity
Suppliers and Packaging for NDA: 020764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764 NDA GlaxoSmithKline LLC 0173-0526 0173-0526-00 100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0526-00)
LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764 NDA GlaxoSmithKline LLC 0173-0527 0173-0527-00 100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0527-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength5MG
Approval Date:Aug 24, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength25MG
Approval Date:Aug 24, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, FOR SUSPENSION;ORALStrength100MG
Approval Date:Aug 24, 1998TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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