Last Updated: May 3, 2026

Details for New Drug Application (NDA): 018731

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NDA 018731 describes BUSPAR, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional details are available on the BUSPAR profile page.

The generic ingredient in BUSPAR is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.

Summary for 018731

Tradename:	BUSPAR
Applicant:	Bristol Myers Squibb
Ingredient:	buspirone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 018731

Anti-Anxiety Agents
Serotonin Receptor Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 29, 1986	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 29, 1986	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 22, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 018731

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-003	Apr 22, 1996	4,215,104	⤷ Start Trial
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-002	Sep 29, 1986	3,177,634	⤷ Start Trial
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-001	Sep 29, 1986	3,177,634	⤷ Start Trial
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-002	Sep 29, 1986	3,717,634	⤷ Start Trial
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-003	Apr 22, 1996	4,258,027	⤷ Start Trial
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-004	Apr 22, 1996	4,215,104	⤷ Start Trial
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-001	Sep 29, 1986	3,717,634	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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