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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077653

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NDA 077653 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Anchen Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Teva, Torrent Pharms Llc, Valeant Pharms North, Wockhardt, Zydus Pharms Usa Inc, Nostrum Labs Inc, Osmotica Pharm, Sun Pharma Global, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Fosun Pharma, Heritage Pharms Inc, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in twenty-seven NDAs. It is available from sixty-nine suppliers. Additional details are available on the VENLAFAXINE HYDROCHLORIDE profile page.

The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 077653
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Zydus Pharms Usa
Ingredient:venlafaxine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077653
Suppliers and Packaging for NDA: 077653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 077653 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6566 N 0615-6566-39
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 077653 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6567 N 0615-6567-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 37.5MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:No

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