Product Details for ANDA 207763
LAMOTRIGINE (LAMOTRIGINE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
250MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 001
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMOTRIGINE (LAMOTRIGINE)
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 001
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 002
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMOTRIGINE (LAMOTRIGINE)
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 002
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 003
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMOTRIGINE (LAMOTRIGINE)
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 003
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 004
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMOTRIGINE (LAMOTRIGINE)
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 004
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
250MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 005
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
LAMOTRIGINE (LAMOTRIGINE)
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 005
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 006
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LAMOTRIGINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207763
Product Number: 006
Approval Date: Apr 1, 2020
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information