Product Details for ANDA 078069
OXCARBAZEPINE (OXCARBAZEPINE)
150MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
600MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXCARBAZEPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078069
Product Number: 001
Approval Date: Jan 11, 2008
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
OXCARBAZEPINE (OXCARBAZEPINE)
Proprietary Name: OXCARBAZEPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078069
Product Number: 001
Approval Date: Jan 11, 2008
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXCARBAZEPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078069
Product Number: 002
Approval Date: Jan 11, 2008
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
OXCARBAZEPINE (OXCARBAZEPINE)
Proprietary Name: OXCARBAZEPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078069
Product Number: 002
Approval Date: Jan 11, 2008
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
600MG
Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXCARBAZEPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078069
Product Number: 003
Approval Date: Jan 11, 2008
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: OXCARBAZEPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078069
Product Number: 003
Approval Date: Jan 11, 2008
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information