Details for New Drug Application (NDA): 077783
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The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 077783
Tradename: | LAMOTRIGINE |
Applicant: | Chartwell Molecular |
Ingredient: | lamotrigine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077783
Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077783
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET;ORAL | 077783 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1512 | 53002-1512-0 | 100 TABLET in 1 BOTTLE (53002-1512-0) |
LAMOTRIGINE | lamotrigine | TABLET;ORAL | 077783 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1512 | 53002-1512-3 | 30 TABLET in 1 BOTTLE (53002-1512-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 1, 2010 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 1, 2010 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 1, 2010 | TE: | RLD: | No |
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