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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Teva
Covington
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Novartis
Chubb
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020764

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NDA 020764 describes LAMICTAL CD, 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 CD profile page.

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

Summary for NDA: 020764

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020764

Suppliers and Packaging for NDA: 020764

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL 020764 NDA GlaxoSmithKline LLC 0173-0526 0173-0526-00 100 TABLET, CHEWABLE in 1 BOTTLE (0173-0526-00)
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL 020764 NDA GlaxoSmithKline LLC 0173-0527 0173-0527-00 100 TABLET, CHEWABLE in 1 BOTTLE (0173-0527-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Aug 24, 1998TE: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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength25MG
Approval Date:Aug 24, 1998TE: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

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength100MG
Approval Date:Aug 24, 1998TE:RLD:No
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

Expired Orange Book Patents for NDA: 020764

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-001Aug 24, 19985,698,226*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-002Aug 24, 19985,698,226*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-004Sep 8, 20004,602,017*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-001Aug 24, 19984,602,017*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-003Aug 24, 19984,602,017*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Baxter
Teva
Healthtrust
Dow
Argus Health
Federal Trade Commission
Harvard Business School
Johnson and Johnson
Queensland Health
Colorcon

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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