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

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 27, 1994	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Dec 27, 1994	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 27, 1994	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020241

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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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