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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076008

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NDA 076008 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 076008
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Mylan
Ingredient:buspirone hydrochloride
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076008
Suppliers and Packaging for NDA: 076008
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008 ANDA Mylan Pharmaceuticals Inc. 0378-1140 N 0378-1140-01
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008 ANDA Mylan Pharmaceuticals Inc. 0378-1140 N 0378-1140-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jun 28, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jul 8, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 1, 2002TE:ABRLD:No

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