Product Details for NDA 022251
LAMICTAL ODT (LAMOTRIGINE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022251
Product Number: 001
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMICTAL ODT (LAMOTRIGINE)
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022251
Product Number: 001
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022251
Product Number: 002
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMICTAL ODT (LAMOTRIGINE)
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022251
Product Number: 002
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022251
Product Number: 003
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMICTAL ODT (LAMOTRIGINE)
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022251
Product Number: 003
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022251
Product Number: 004
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LAMICTAL ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022251
Product Number: 004
Approval Date: May 8, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information