NDA 021589

UCB INC

FDA Drug Application

Application #021589

Documents

• Review: 2006-07-25
• Letter: 2003-11-05
• Label: 2003-11-05

Application Sponsors

NDA 021589

UCB INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	0	KEMSTRO	BACLOFEN
002	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	0	KEMSTRO	BACLOFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2003-10-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21589
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KEMSTRO","activeIngredients":"BACLOFEN","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KEMSTRO","activeIngredients":"BACLOFEN","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/30\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21589_kemstro_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KEMSTRO","submission":"BACLOFEN","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KEMSTRO","submission":"BACLOFEN","actionType":"20MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-10-30
        )

)