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Last Updated: October 20, 2021

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Details for New Drug Application (NDA): 214654


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NDA 214654 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Anchen Pharms, Annora Pharma, Atlantide, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Teva, Torrent, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel Pharma, Nostrum Labs Inc, Osmotica Pharm, Sun Pharm, 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 thirty-eight NDAs. It is available from fifty-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. Sixty suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 214654
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Yichang Humanwell
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:Aug 6, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:Aug 6, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 6, 2021TE:ABRLD:No

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