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Queensland Health
Chinese Patent Office
Colorcon
Citi
Harvard Business School
Federal Trade Commission
McKesson
Johnson and Johnson
Deloitte

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078246

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NDA 078246 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Egis, Fosun Pharma, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Orion Corp Orion, Oxford Pharms, Strides Pharma, Teva, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from fifty suppliers. Additional details are available on the BUSPIRONE HYDROCHLORIDE profile page.

The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are eighteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 078246
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:buspirone hydrochloride
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078246
Suppliers and Packaging for NDA: 078246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078246 ANDA Dr. Reddy's Laboratories Limited 55111-472 N 55111-472-01
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078246 ANDA Dr. Reddy's Laboratories Limited 55111-472 N 55111-472-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 27, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 27, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Feb 27, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Dow
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Boehringer Ingelheim
US Army
Chubb
QuintilesIMS
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Fish and Richardson

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