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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075119

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NDA 075119 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 075119

Tradename:	BUSPIRONE HYDROCHLORIDE
Applicant:	Egis
Ingredient:	buspirone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075119

Anti-Anxiety Agents
Serotonin Receptor Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 14, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 14, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jan 23, 2003	TE:		RLD:	No

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