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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 208972


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NDA 208972 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rising, Rubicon, Strides Pharma, Teva, Unichem, and Zydus Pharms, and is included in twenty-one NDAs. It is available from forty-three 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-three suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 208972
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:buspirone hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 208972
Suppliers and Packaging for NDA: 208972
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208972 ANDA Epic Pharma, LLC 42806-082 42806-082-01 100 TABLET in 1 BOTTLE (42806-082-01)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208972 ANDA Epic Pharma, LLC 42806-082 42806-082-05 500 TABLET in 1 BOTTLE (42806-082-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 16, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Apr 16, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 16, 2019TE:ABRLD:No

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