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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022251


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NDA 022251 describes LAMICTAL ODT, 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 ODT profile page.

The generic ingredient in LAMICTAL ODT 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 022251
Tradename:LAMICTAL ODT
Applicant:Glaxosmithkline Llc
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 NDA GlaxoSmithKline LLC 0173-0772 0173-0772-02 1 DOSE PACK in 1 CARTON (0173-0772-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK
LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 NDA GlaxoSmithKline LLC 0173-0774 0173-0774-02 1 DOSE PACK in 1 CARTON (0173-0774-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:May 8, 2009TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength50MG
Approval Date:May 8, 2009TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:May 8, 2009TE:ABRLD:Yes

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