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Last Updated: March 28, 2024

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 are thirty-two drug master file entries for this compound. Fifty-one 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
Formulation / Manufacturing:see details
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

Expired US Patents for NDA 020764

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-004 Sep 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-002 Aug 24, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-003 Aug 24, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-004 Sep 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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