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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 078865


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NDA 078865 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Mylan, Nostrum Pharms Llc, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Nostrum Labs Inc, Osmotica Pharm Us, Sun Pharm, Sunny, Unique, Zydus Pharms, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage Pharms, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-four NDAs. It is available from sixty-eight 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 suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 078865
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Wockhardt Bio Ag
Ingredient:venlafaxine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:Apr 14, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:Apr 14, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:Apr 14, 2011TE:ABRLD:No

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