Details for New Drug Application (NDA): 022251
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NDA 022251 describes LAMICTAL ODT, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the LAMICTAL ODT profile page.
The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three 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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