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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208209


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NDA 208209 describes VILAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Invagen Pharms, and Teva Pharms Usa, and is included in five NDAs. It is available from twelve suppliers. Additional details are available on the VILAZODONE HYDROCHLORIDE profile page.

The generic ingredient in VILAZODONE HYDROCHLORIDE is vilazodone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.
Summary for 208209
Tradename:VILAZODONE HYDROCHLORIDE
Applicant:Accord Hlthcare
Ingredient:vilazodone hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 208209
Antidepressive Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 208209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VILAZODONE HYDROCHLORIDE vilazodone hydrochloride TABLET;ORAL 208209 ANDA Accord Healthcare Inc. 16729-352 16729-352-10 30 TABLET in 1 BOTTLE (16729-352-10)
VILAZODONE HYDROCHLORIDE vilazodone hydrochloride TABLET;ORAL 208209 ANDA Accord Healthcare Inc. 16729-353 16729-353-10 30 TABLET in 1 BOTTLE (16729-353-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 27, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 27, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 27, 2021TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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