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-three 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 Action	Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors
Physiological Effect	Decreased 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:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	5MG
Approval Date:	Aug 24, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	25MG
Approval Date:	Aug 24, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	100MG
Approval Date:	Aug 24, 1998	TE:		RLD:	No

Expired US Patents for NDA 020764

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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	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-001	Aug 24, 1998	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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