Details for New Drug Application (NDA): 079099
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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 079099
Tradename: | LAMOTRIGINE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | lamotrigine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079099
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: 079099
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 079099 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-228 | 68462-228-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (68462-228-01) |
LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 079099 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-228 | 68462-228-10 | 1000 TABLET, CHEWABLE in 1 BOTTLE (68462-228-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 19, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 19, 2009 | TE: | AB | RLD: | No |
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