Details for New Drug Application (NDA): 021190

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NDA 021190 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-three suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.

Summary for 021190

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

Medical Subject Heading (MeSH) Categories for 021190

Anti-Anxiety Agents
Serotonin Receptor Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 2000	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021190

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	CAPSULE;ORAL	021190-001	Dec 20, 2000	5,015,646*PED	⤷ Subscribe
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	CAPSULE;ORAL	021190-004	Dec 20, 2000	5,015,646*PED	⤷ Subscribe
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	CAPSULE;ORAL	021190-003	Dec 20, 2000	5,015,646*PED	⤷ Subscribe
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	CAPSULE;ORAL	021190-002	Dec 20, 2000	5,015,646*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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