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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021589

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NDA 021589 describes KEMSTRO, which is a drug marketed by Ucb Inc and is included in one NDA. Additional details are available on the KEMSTRO profile page.

The generic ingredient in KEMSTRO is baclofen. There are twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 021589

Tradename:	KEMSTRO
Applicant:	Ucb Inc
Ingredient:	baclofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 021589

GABA-B Receptor Agonists
Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 30, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 30, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021589

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003	⤷ Get Started Free	⤷ Get Started Free
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003	⤷ Get Started Free	⤷ Get Started Free
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003	⤷ Get Started Free	⤷ Get Started Free
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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