NDA 021712

UCB INC

FDA Drug Application

Application #021712

Documents

• Letter: 2004-09-29
• Review: 2007-03-30
• Label: 2004-09-29

Application Sponsors

NDA 021712

UCB INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	0	FLUXID	FAMOTIDINE
002	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	0	FLUXID	FAMOTIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2004-09-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21712
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUXID","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUXID","activeIngredients":"FAMOTIDINE","strength":"40MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/24\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21712lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLUXID","submission":"FAMOTIDINE","actionType":"20MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUXID","submission":"FAMOTIDINE","actionType":"40MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-09-24
        )

)