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Details for New Drug Application (NDA): 020241
The generic ingredient in LAMICTAL is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 020241
Tradename: | LAMICTAL |
Applicant: | Glaxosmithkline Llc |
Ingredient: | lamotrigine |
Patents: | 0 |
Therapeutic Class: | Anticonvulsants Bipolar Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020241
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 020241
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMICTAL | lamotrigine | TABLET;ORAL | 020241 | NDA | GlaxoSmithKline LLC | 0173-0594 | N | 0173-0594-02 |
LAMICTAL | lamotrigine | TABLET;ORAL | 020241 | NDA | GlaxoSmithKline LLC | 0173-0633 | N | 0173-0633-10 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 27, 1994 | TE: | AB | RLD: | 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 |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Dec 27, 1994 | TE: | AB | RLD: | 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 |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Dec 27, 1994 | TE: | AB | RLD: | 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 |
Expired US Patents for NDA 020241
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | ➤ Sign Up | ➤ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | ➤ Sign Up | ➤ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-001 | Dec 27, 1994 | ➤ Sign Up | ➤ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-006 | Dec 27, 1994 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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