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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074253

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NDA 074253 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Apotex, Dr Reddys Labs 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-one 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-one suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 074253
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Impax Labs Inc
Ingredient:buspirone hydrochloride
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074253
Suppliers and Packaging for NDA: 074253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 074253 ANDA Impax Generics 0115-1690 N 0115-1690-02
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 074253 ANDA Impax Generics 0115-1690 N 0115-1690-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 28, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 28, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Mar 13, 2002TE:ABRLD:No

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