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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211323


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NDA 211323 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 211323
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Cadila Pharms Ltd
Ingredient:venlafaxine hydrochloride
Patents:0
Pharmacology for NDA: 211323
Suppliers and Packaging for NDA: 211323
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 211323 ANDA Cadila Pharmaceuticals Limited 71209-087 71209-087-01 30 TABLET, COATED in 1 BOTTLE (71209-087-01)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 211323 ANDA Cadila Pharmaceuticals Limited 71209-087 71209-087-04 90 TABLET, COATED in 1 BOTTLE (71209-087-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:Aug 29, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 29, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 225MG BASE
Approval Date:Aug 29, 2019TE:ABRLD:No

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