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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075022

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NDA 075022 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Apotex, Dr Reddys Labs Ltd, Egis, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Orion Corp Orion, Oxford Pharms, Sandoz, 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 075022

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 075022

Suppliers and Packaging for NDA: 075022

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075022 ANDA Teva Pharmaceuticals USA, Inc. 0093-0053 0093-0053-05 500 TABLET in 1 BOTTLE (0093-0053-05)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075022 ANDA Teva Pharmaceuticals USA, Inc. 0093-0053 0093-0053-01 100 TABLET in 1 BOTTLE (0093-0053-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Feb 28, 2002TE:ABRLD:No


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