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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022104

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NDA 022104 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Anchen Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Teva, Torrent Pharms Llc, Valeant Pharms North, Wockhardt, Zydus Pharms Usa Inc, Nostrum Labs Inc, Osmotica Pharm, Sun Pharma Global, 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 twenty-seven NDAs. It is available from seventy-one 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-five suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 022104
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Osmotica Pharm
Ingredient:venlafaxine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 022104
Suppliers and Packaging for NDA: 022104
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104 NDA UCB, Inc. 0131-3267 N 0131-3267-46
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104 NDA UCB, Inc. 0131-3267 N 0131-3267-32

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:May 20, 2008TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:May 20, 2008TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:May 20, 2008TE:ABRLD:Yes

Expired US Patents for NDA 022104

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-002 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-001 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-001 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-002 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-004 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-004 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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