Product Details for NDA 202810
OXTELLAR XR (OXCARBAZEPINE)
150MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
600MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXTELLAR XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202810
Product Number: 001
Approval Date: Oct 19, 2012
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
OXTELLAR XR (OXCARBAZEPINE)
Proprietary Name: OXTELLAR XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202810
Product Number: 001
Approval Date: Oct 19, 2012
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXTELLAR XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202810
Product Number: 002
Approval Date: Oct 19, 2012
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
OXTELLAR XR (OXCARBAZEPINE)
Proprietary Name: OXTELLAR XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202810
Product Number: 002
Approval Date: Oct 19, 2012
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
600MG
Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXTELLAR XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202810
Product Number: 003
Approval Date: Oct 19, 2012
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: OXTELLAR XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202810
Product Number: 003
Approval Date: Oct 19, 2012
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information