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Last Updated: March 29, 2024

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 is one patent 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. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 022115
Tradename:LAMICTAL XR
Applicant:Glaxosmithkline Llc
Ingredient:lamotrigine
Patents:1
Formulation / Manufacturing:see details
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:May 29, 2009TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 14, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:May 29, 2009TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 14, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022115

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-001 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-005 Apr 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-002 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-006 Jun 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-003 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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