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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078301

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NDA 078301 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Osmotica Pharm, Sandoz, Pliva Hrvatska Doo, Orchid Hlthcare, Prinston Inc, Sun Pharm Inds Inc, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Yaopharma Co Ltd, Zydus Pharms Usa, Heritage Pharms Inc, Aurobindo Pharma, Teva, Wockhardt, Mylan, Nostrum Labs Inc, Valeant Pharms North, Sun Pharma Global, Zydus Pharms Usa Inc, Anchen Pharms, Amneal Pharms, and Torrent Pharms Llc, and is included in twenty-six NDAs. It is available from sixty-seven suppliers. There are two patents protecting this drug. Additional details are available on the VENLAFAXINE HYDROCHLORIDE profile page.

The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for NDA: 078301

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078301

Suppliers and Packaging for NDA: 078301

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL 078301 ANDA KAISER FOUNDATION HOSPITALS 0179-0107 0179-0107-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0107-70)
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL 078301 ANDA KAISER FOUNDATION HOSPITALS 0179-0108 0179-0108-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0108-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 37.5MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Baxter
McKesson
Cipla
Deloitte
Merck
Chubb
Argus Health
Covington
Medtronic
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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