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Generated: April 24, 2017

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Details for New Drug Application (NDA): 078087

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NDA 078087 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Osmotica Pharm, Sandoz, Pliva Hrvatska Doo, Orchid Hlthcare, Prinston Inc, Sun Pharm Inds Inc, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Yaopharma Co Ltd, Zydus Pharms Usa, Heritage Pharms Inc, Aurobindo Pharma, Teva, Wockhardt, Mylan, Nostrum Labs Inc, Valeant Pharms North, Sun Pharma Global, Zydus Pharms Usa Inc, Anchen Pharms, Amneal Pharms, and Torrent Pharms Llc, and is included in twenty-six NDAs. It is available from sixty-seven 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 drug master file entries for this compound. Seventy-three suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for NDA: 078087

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:Mar 16, 2012TE:ABRLD:No

Summary for product number 002

Approval Date:Mar 16, 2012TE:ABRLD:No

Summary for product number 003

Approval Date:Mar 16, 2012TE:ABRLD:No

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