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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078627

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NDA 078627 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, Heritage Pharms Inc, Pliva Hrvatska Doo, Prinston Inc, Sandoz, 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. There are two patents protecting this drug. 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-five suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for 078627

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078627

Suppliers and Packaging for NDA: 078627

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078627 ANDA Northstar Rx LLC 16714-655 16714-655-01 100 TABLET in 1 BOTTLE (16714-655-01)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078627 ANDA Northstar Rx LLC 16714-656 16714-656-01 100 TABLET in 1 BOTTLE (16714-656-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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