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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Fish and Richardson
Harvard Business School
Express Scripts
Dow
Citi
Chubb
Chinese Patent Office
Healthtrust

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078888

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NDA 078888 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 078888
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:buspirone hydrochloride
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078888
Suppliers and Packaging for NDA: 078888
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078888 ANDA Aidarex Pharmaceuticals LLC 53217-276 53217-276-30 30 TABLET in 1 BOTTLE (53217-276-30)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078888 ANDA Aidarex Pharmaceuticals LLC 53217-276 53217-276-60 60 TABLET in 1 BOTTLE (53217-276-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 7, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 7, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Feb 7, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
Citi
Queensland Health
Merck
Cipla
Daiichi Sankyo
Federal Trade Commission
Boehringer Ingelheim

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