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US Army
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Colorcon
Dow
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Chinese Patent Office
Cerilliant
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075385

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NDA 075385 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 075385
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Ivax Sub Teva Pharms
Ingredient:buspirone hydrochloride
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075385
Suppliers and Packaging for NDA: 075385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075385 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-4575 N 0615-4575-31
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075385 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-4575 N 0615-4575-39

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 1, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 1, 2002TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 1, 2002TE:RLD:No

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