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Generated: June 24, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Anticonvulsants Bipolar Agents |
| Formulation / Manufacturing: | see details |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| 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) |
| 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 | ||||||||
| 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 | ||||||||
| 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 | ||||||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-006 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-001 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-005 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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