Product Details for ANDA 208209
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: A208209
Product Number: 001
Approval Date: Apr 27, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE 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: A208209
Product Number: 001
Approval Date: Apr 27, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE 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: A208209
Product Number: 002
Approval Date: Apr 27, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE 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: A208209
Product Number: 002
Approval Date: Apr 27, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE 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: A208209
Product Number: 003
Approval Date: Apr 27, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE 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: A208209
Product Number: 003
Approval Date: Apr 27, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information