Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021589
Company: UCB INC

Products on NDA 021589

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEMSTRO	BACLOFEN	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
KEMSTRO	BACLOFEN	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021589

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21589_kemstro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21589ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021589s000_KemstroTOC.cfm

Labels for NDA 021589

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21589_kemstro_lbl.pdf