UCB INC FDA Approval NDA 021505

NDA 021505

UCB INC

FDA Drug Application

Application #021505

Documents

Letter2006-08-18
Letter2007-03-23
Letter2007-09-25
Letter2011-12-21
Letter2011-12-21
Letter2011-12-21
Letter2014-08-11
Label2005-06-23
Label2007-03-23
Label2011-12-20
Label2011-12-20
Label2014-08-08
Review2004-11-01
Letter2003-07-28
Letter2004-10-29
Letter2004-10-29
Letter2006-01-30
Letter2005-06-23
Letter2011-12-21
Letter2009-05-04
Letter2009-05-04
Letter2011-08-12
Letter2013-07-26
Letter2014-03-11
Letter2015-03-12
Label2006-08-18
Label2011-12-20
Label2009-05-13
Label2009-05-13
Label2011-12-20
Label2013-07-30
Label2014-03-10
Label2015-03-12
Other Important Information from FDA2007-03-28
Letter2016-10-28
Label2016-11-01
Label2017-04-25
Letter2017-04-27
Label2017-10-25
Letter2017-10-30
Label2019-10-24
Medication Guide2019-10-24
Letter2019-10-24
Letter2020-10-01
Label2020-10-02
Medication Guide2020-10-02

Application Sponsors

NDA 021505UCB INC

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL100MG/ML1KEPPRALEVETIRACETAM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2003-07-15STANDARD
LABELING; LabelingSUPPL2AP2004-10-26STANDARD
LABELING; LabelingSUPPL3AP2004-10-26STANDARD
LABELING; LabelingSUPPL6AP2006-01-24STANDARD
EFFICACY; EfficacySUPPL7AP2005-06-21PRIORITY
EFFICACY; EfficacySUPPL9AP2006-08-15UNKNOWN
EFFICACY; EfficacySUPPL13AP2007-03-19STANDARD
LABELING; LabelingSUPPL15AP2007-09-12STANDARD
EFFICACY; EfficacySUPPL19AP2011-12-16PRIORITY
LABELING; LabelingSUPPL20AP2011-12-16STANDARD
LABELING; LabelingSUPPL21AP2009-04-23901 REQUIRED
LABELING; LabelingSUPPL22AP2009-04-23STANDARD
LABELING; LabelingSUPPL24AP2009-04-23STANDARD
LABELING; LabelingSUPPL25AP2011-12-16STANDARD
LABELING; LabelingSUPPL26AP2011-12-16STANDARD
REMS; REMSSUPPL29AP2011-08-10N/A
LABELING; LabelingSUPPL30AP2013-07-25UNKNOWN
LABELING; LabelingSUPPL31AP2014-03-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2013-09-13STANDARD
LABELING; LabelingSUPPL33AP2015-03-10STANDARD
LABELING; LabelingSUPPL34AP2014-08-07STANDARD
LABELING; LabelingSUPPL36AP2016-10-26STANDARD
LABELING; LabelingSUPPL38AP2017-04-24STANDARD
LABELING; LabelingSUPPL40AP2017-10-24STANDARD
EFFICACY; EfficacySUPPL42AP2019-10-23STANDARD
LABELING; LabelingSUPPL44AP2020-09-30STANDARD

Submissions Property Types

SUPPL15Null6
SUPPL19Null7
SUPPL20Null7
SUPPL24Null7
SUPPL25Null6
SUPPL26Null6
SUPPL29Null15
SUPPL30Null15
SUPPL31Null6
SUPPL32Null0
SUPPL33Null15
SUPPL34Null6
SUPPL36Null6
SUPPL38Null15
SUPPL40Null31
SUPPL42Null15
SUPPL44Null7

TE Codes

001PrescriptionAA

CDER Filings

UCB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21505
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021035s102,021505s042lbl.pdf#page=32"]
            [products] => [{"drugName":"KEPPRA","activeIngredients":"LEVETIRACETAM","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/23\/2019","submission":"SUPPL-42","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021035s102,021505s042lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021035s100,021505s040lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021035s099,021505s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2016","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021035s096,021505s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021035s093,021505s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021035s093,021505s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021035s089,021505s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-19","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-24","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"03\/19\/2007","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021035s057,021505s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2006","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021035s050s054,021505s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2005","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021035s040,021505s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KEPPRA","submission":"LEVETIRACETAM","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-23
        )

)
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