Details for New Drug Application (NDA): 022251
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The generic ingredient in LAMICTAL ODT is lamotrigine. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 022251
| Tradename: | LAMICTAL ODT |
| Applicant: | Glaxosmithkline Llc |
| Ingredient: | lamotrigine |
| Patents: | 0 |
Pharmacology for NDA: 022251
| 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: 022251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251 | NDA | GlaxoSmithKline LLC | 0173-0772 | 0173-0772-02 | 1 DOSE PACK in 1 CARTON (0173-0772-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK |
| LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251 | NDA | GlaxoSmithKline LLC | 0173-0774 | 0173-0774-02 | 1 DOSE PACK in 1 CARTON (0173-0774-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 25MG | ||||
| Approval Date: | May 8, 2009 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 50MG | ||||
| Approval Date: | May 8, 2009 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 100MG | ||||
| Approval Date: | May 8, 2009 | TE: | AB | RLD: | Yes | ||||
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