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Details for New Drug Application (NDA): 020241
NDA 020241 describes LAMICTAL, which is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. It is available from four suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LAMICTAL profile page.
The generic ingredient in LAMICTAL is lamotrigine. There are thirty-two drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
The generic ingredient in LAMICTAL is lamotrigine. There are thirty-two drug master file entries for this compound. Sixty-two 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 |
| 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 | 0173-0594-02 | 1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0594-02) > 1 KIT in 1 BLISTER PACK |
| LAMICTAL | lamotrigine | TABLET;ORAL | 020241 | NDA | GlaxoSmithKline LLC | 0173-0633 | 0173-0633-02 | 100 TABLET in 1 BOTTLE (0173-0633-02) |
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 | 020241-005 | Dec 27, 1994 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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