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Last Updated: September 21, 2020

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Details for New Drug Application (NDA): 075413

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NDA 075413 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Fosun Pharma, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rubicon, Strides Pharma, Teva, Unichem Labs Ltd, Yiling Pharm Ltd, and Zydus Pharms, and is included in twenty-one NDAs. It is available from forty-two suppliers. Additional details are available on the BUSPIRONE HYDROCHLORIDE profile page.

The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 075413
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Fosun Pharma
Ingredient:buspirone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075413

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Mar 19, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Mar 19, 2002TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength15MG
Approval Date:Mar 19, 2002TE:RLD:No

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