Details for New Drug Application (NDA): 020241
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The generic ingredient in LAMICTAL 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 020241
Tradename: | LAMICTAL |
Applicant: | Glaxosmithkline Llc |
Ingredient: | lamotrigine |
Patents: | 0 |
Pharmacology for NDA: 020241
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: 020241
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMICTAL | lamotrigine | TABLET;ORAL | 020241 | NDA | GlaxoSmithKline LLC | 0173-0594 | 0173-0594-02 | 1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0594-02) / 1 KIT in 1 BLISTER PACK |
LAMICTAL | lamotrigine | TABLET;ORAL | 020241 | NDA | GlaxoSmithKline LLC | 0173-0633 | 0173-0633-02 | 100 TABLET in 1 BOTTLE (0173-0633-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 27, 1994 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Dec 27, 1994 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Dec 27, 1994 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020241
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-005 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-001 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-006 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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