Product Details for NDA 020764
LAMICTAL CD (LAMOTRIGINE)
2MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
100MG
Marketing Status: Discontinued
2MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020764
Product Number: 004
Approval Date: Sep 8, 2000
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMICTAL CD (LAMOTRIGINE)
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020764
Product Number: 004
Approval Date: Sep 8, 2000
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020764
Product Number: 001
Approval Date: Aug 24, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMICTAL CD (LAMOTRIGINE)
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020764
Product Number: 001
Approval Date: Aug 24, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020764
Product Number: 002
Approval Date: Aug 24, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMICTAL CD (LAMOTRIGINE)
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020764
Product Number: 002
Approval Date: Aug 24, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Discontinued
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020764
Product Number: 003
Approval Date: Aug 24, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LAMICTAL CD
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020764
Product Number: 003
Approval Date: Aug 24, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information