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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 020241


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NDA 020241 describes LAMICTAL, which is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LAMICTAL profile page.

The generic ingredient in LAMICTAL is lamotrigine. There are thirty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 020241
Tradename:LAMICTAL
Applicant:Glaxosmithkline Llc
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020241
Suppliers and Packaging for NDA: 020241
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL lamotrigine TABLET;ORAL 020241 NDA GlaxoSmithKline LLC 0173-0594 0173-0594-02 1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0594-02) > 1 KIT in 1 BLISTER PACK
LAMICTAL lamotrigine TABLET;ORAL 020241 NDA GlaxoSmithKline LLC 0173-0633 0173-0633-02 100 TABLET in 1 BOTTLE (0173-0633-02)
Paragraph IV (Patent) Challenges for 020241
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL TABLET;ORAL lamotrigine 020241

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 27, 1994TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 27, 1994TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 27, 1994TE:ABRLD:Yes

Expired US Patents for NDA 020241

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-002 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-001 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-006 Dec 27, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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