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Generated: August 18, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 0 |
| 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 | 020241-006 | Dec 27, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-001 | Dec 27, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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