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Details for New Drug Application (NDA): 022115

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NDA 022115 describes LAMICTAL XR, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LAMICTAL XR profile page.

The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the lamotrigine profile page.

Summary for NDA: 022115

Tradename:
LAMICTAL XR
Applicant:
Glaxosmithkline Llc
Ingredient:
lamotrigine
Patents:2
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022115

Suppliers and Packaging for NDA: 022115

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL 022115 NDA GlaxoSmithKline LLC 0173-0754 0173-0754-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0754-00)
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL 022115 NDA GlaxoSmithKline LLC 0173-0755 0173-0755-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0755-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:May 29, 2009TE:ABRLD:No
Patent:8,637,512Patent Expiration:Jun 14, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:9,144,547Patent Expiration:Sep 22, 2023Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:May 29, 2009TE:ABRLD:Yes
Patent:8,637,512Patent Expiration:Jun 14, 2028Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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