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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 078302

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NDA 078302 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 Research, Strides Pharma, Teva, Unichem, 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-six suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.

Summary for 078302

Tradename:	BUSPIRONE HYDROCHLORIDE
Applicant:	Oxford Pharms
Ingredient:	buspirone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078302

Anti-Anxiety Agents
Serotonin Receptor Agonists

Suppliers and Packaging for NDA: 078302

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUSPIRONE HYDROCHLORIDE	buspirone hydrochloride	TABLET;ORAL	078302	ANDA	A-S Medication Solutions	50090-7742	50090-7742-0	60 TABLET in 1 BOTTLE (50090-7742-0)
BUSPIRONE HYDROCHLORIDE	buspirone hydrochloride	TABLET;ORAL	078302	ANDA	A-S Medication Solutions	50090-7742	50090-7742-1	90 TABLET in 1 BOTTLE (50090-7742-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Dec 17, 2007	TE:	AB	RLD:	No

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