Product Details for ANDA 208228
VILAZODONE HYDROCHLORIDE (VILAZODONE HYDROCHLORIDE)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
Active Ingredient: VILAZODONE HYDROCHLORIDE
Proprietary Name: VILAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208228
Product Number: 001
Approval Date: Jul 7, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
VILAZODONE HYDROCHLORIDE (VILAZODONE HYDROCHLORIDE)
Proprietary Name: VILAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208228
Product Number: 001
Approval Date: Jul 7, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: VILAZODONE HYDROCHLORIDE
Proprietary Name: VILAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208228
Product Number: 002
Approval Date: Jul 7, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
VILAZODONE HYDROCHLORIDE (VILAZODONE HYDROCHLORIDE)
Proprietary Name: VILAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208228
Product Number: 002
Approval Date: Jul 7, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: VILAZODONE HYDROCHLORIDE
Proprietary Name: VILAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208228
Product Number: 003
Approval Date: Jul 7, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: VILAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208228
Product Number: 003
Approval Date: Jul 7, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information