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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Express Scripts

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075467

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NDA 075467 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, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Orion Corp Orion, Oxford Pharms, Strides Pharma, Teva, and Zydus Pharms Usa Inc, and is included in nineteen 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 075467
Ingredient:buspirone hydrochloride
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075467
Suppliers and Packaging for NDA: 075467
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075467 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5548 N 0615-5548-39
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075467 ANDA AvKARE, Inc. 42291-176 N 42291-176-90

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Feb 28, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Mar 28, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Feb 28, 2002TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson

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