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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-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: 022251

Tradename:
LAMICTAL ODT
Applicant:
Glaxosmithkline Llc
Ingredient:
lamotrigine
Patents:3
Therapeutic Class:Anticonvulsants
Bipolar Agents
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 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (0173-0772-02)
LAMICTAL ODT
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL 022251 NDA GlaxoSmithKline LLC 0173-0774 0173-0774-02 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (0173-0774-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:May 8, 2009TE:ABRLD:No
Patent:7,919,115Patent Expiration:Jan 4, 2029Product Flag?YSubstance Flag?YDelist Request?
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:8,840,925Patent 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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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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