Details for New Drug Application (NDA): 022115
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The generic ingredient in LAMICTAL XR 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 022115
Tradename: | LAMICTAL XR |
Applicant: | Glaxosmithkline Llc |
Ingredient: | lamotrigine |
Patents: | 1 |
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: | ⤷ Sign Up | Patent Expiration: | Jun 14, 2028 | 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: | ⤷ Sign Up | Patent Expiration: | Jun 14, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | May 29, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 14, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022115
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-001 | May 29, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-006 | Jun 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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