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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 076690


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NDA 076690 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Norvium Bioscience, 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, Swiss Pharm, Unique, Zydus Pharms, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-five NDAs. It is available from sixty-five 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-eight suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 076690
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Teva
Ingredient:venlafaxine hydrochloride
Patents:0
Pharmacology for NDA: 076690
Suppliers and Packaging for NDA: 076690
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 076690 ANDA Teva Pharmaceuticals USA, Inc. 0093-9147 0093-9147-01 100 TABLET in 1 BOTTLE (0093-9147-01)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 076690 ANDA Teva Pharmaceuticals USA, Inc. 0093-9148 0093-9148-01 100 TABLET in 1 BOTTLE (0093-9148-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Aug 3, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 37.5MG BASE
Approval Date:Aug 3, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 3, 2006TE:ABRLD:No

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