Details for New Drug Application (NDA): 201168
✉ Email this page to a colleague
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 201168
Tradename: | LAMOTRIGINE |
Applicant: | Alembic |
Ingredient: | lamotrigine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201168
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: 201168
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 201168 | ANDA | Alembic Pharmaceuticals Limited | 46708-095 | 46708-095-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-30) |
LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 201168 | ANDA | Alembic Pharmaceuticals Limited | 46708-095 | 46708-095-31 | 100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 12, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 12, 2014 | TE: | AB | RLD: | No |
Complete Access Available with Subscription