Details for New Drug Application (NDA): 022115
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NDA 022115 describes LAMICTAL XR, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LAMICTAL XR profile page.
The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 022115
| Tradename: | LAMICTAL XR |
| Applicant: | Glaxosmithkline Llc |
| Ingredient: | lamotrigine |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022115
| 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: 022115
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | NDA | GlaxoSmithKline LLC | 0173-0754 | 0173-0754-00 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0754-00) |
| LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | NDA | GlaxoSmithKline LLC | 0173-0755 | 0173-0755-00 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0755-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | May 29, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 14, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 22, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
| Approval Date: | May 29, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 14, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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