Details for New Drug Application (NDA): 020764
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NDA 020764 describes LAMICTAL CD, 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 CD profile page.
The generic ingredient in LAMICTAL CD 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 CD 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 020764
| Tradename: | LAMICTAL CD |
| Applicant: | Glaxosmithkline Llc |
| Ingredient: | lamotrigine |
| Patents: | 0 |
Pharmacology for NDA: 020764
| 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: 020764
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764 | NDA | GlaxoSmithKline LLC | 0173-0526 | 0173-0526-00 | 100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0526-00) |
| LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764 | NDA | GlaxoSmithKline LLC | 0173-0527 | 0173-0527-00 | 100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0527-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 24, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 24, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 24, 1998 | TE: | RLD: | No | |||||
Expired US Patents for NDA 020764
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-001 | Aug 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-003 | Aug 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-004 | Sep 8, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-002 | Aug 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-003 | Aug 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-001 | Aug 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-002 | Aug 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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