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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020241

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LAMICTAL (LAMOTRIGINE)
25MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020241
Product Number: 005
Approval Date: Dec 27, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL (LAMOTRIGINE)
100MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020241
Product Number: 001
Approval Date: Dec 27, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL (LAMOTRIGINE)
150MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020241
Product Number: 002
Approval Date: Dec 27, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL (LAMOTRIGINE)
200MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020241
Product Number: 003
Approval Date: Dec 27, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL (LAMOTRIGINE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020241
Product Number: 006
Approval Date: Dec 27, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LAMICTAL (LAMOTRIGINE)
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020241
Product Number: 004
Approval Date: Dec 27, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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