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Last Updated: November 14, 2019

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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-six 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
Pharmacology for NDA: 020764
Suppliers and Packaging for NDA: 020764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764 NDA GlaxoSmithKline LLC 0173-0526 0173-0526-00 100 TABLET, CHEWABLE in 1 BOTTLE (0173-0526-00)
LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764 NDA GlaxoSmithKline LLC 0173-0527 0173-0527-00 100 TABLET, CHEWABLE in 1 BOTTLE (0173-0527-00)
Paragraph IV (Patent) Challenges for 020764
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL CD TABLET, CHEWABLE;ORAL lamotrigine 020764

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;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, CHEWABLE;ORAL 020764-003 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-001 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-002 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-001 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-003 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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