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Details for New Drug Application (NDA): 022567

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NDA 022567 describes VIIBRYD, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VIIBRYD profile page.

The generic ingredient in VIIBRYD is vilazodone hydrochloride. There are thirteen drug master file entries for this compound. Three suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the vilazodone hydrochloride profile page.

Summary for NDA: 022567

Forest Labs Llc
vilazodone hydrochloride
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022567

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vilazodone hydrochloride
TABLET;ORAL 022567 NDA Allergan, Inc. 0456-1100 0456-1100-31 1 KIT in 1 BLISTER PACK (0456-1100-31)
vilazodone hydrochloride
TABLET;ORAL 022567 NDA Allergan, Inc. 0456-1101 0456-1101-30 1 KIT in 1 BLISTER PACK (0456-1101-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 21, 2011TE:RLD:Yes
Patent:5,532,241Patent Expiration:Sep 29, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:8,673,921Patent Expiration:Jun 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Mar 16, 2018

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