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Generated: January 16, 2019

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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. There are three patents protecting this drug and one Paragraph IV challenge. 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. Sixty-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:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 022251
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
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
Patent:➤ Sign UpPatent Expiration:Jan 4, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Jul 2, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Harvard Business School
Boehringer Ingelheim
Healthtrust
Teva
Fuji
Johnson and Johnson
Colorcon
Argus Health

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