Details for New Drug Application (NDA): 090401
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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 090401
Tradename: | LAMOTRIGINE |
Applicant: | Aurobindo Pharma |
Ingredient: | lamotrigine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090401
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: 090401
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 090401 | ANDA | Rising Pharma Holdings, Inc. | 16571-785 | 16571-785-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (16571-785-01) |
LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 090401 | ANDA | Rising Pharma Holdings, Inc. | 16571-786 | 16571-786-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (16571-786-01) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 4, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 4, 2009 | TE: | AB | RLD: | No |
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