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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Fish and Richardson
Harvard Business School
US Department of Justice

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076008

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NDA 076008 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Apotex, Dr Reddys Labs Ltd, Egis, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Orion Corp Orion, Oxford Pharms, Sandoz, Strides Pharma, Teva, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from fifty-two 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-two suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 076008
Ingredient:buspirone hydrochloride
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076008
Suppliers and Packaging for NDA: 076008
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008 ANDA Mylan Pharmaceuticals Inc. 0378-1140 0378-1140-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-1140-05)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008 ANDA Mylan Pharmaceuticals Inc. 0378-1140 0378-1140-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1140-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jun 28, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jul 8, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 1, 2002TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Harvard Business School
Queensland Health
Cantor Fitzgerald
Chinese Patent Office

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