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Last Updated: June 13, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202087


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NDA 202087 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, Yiling, and Zydus Pharms, and is included in twenty-one NDAs. It is available from forty-five 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-five suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 202087
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Yiling
Ingredient:buspirone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202087
Suppliers and Packaging for NDA: 202087
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202087 ANDA EPIC PHARMA, LLC 42806-662 42806-662-01 100 TABLET in 1 BOTTLE (42806-662-01)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202087 ANDA EPIC PHARMA, LLC 42806-662 42806-662-05 500 TABLET in 1 BOTTLE (42806-662-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 16, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 16, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 16, 2015TE:ABRLD:No

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