UCB INC FDA Approval NDA 021872

NDA 021872

UCB INC

FDA Drug Application

Application #021872

Documents

Letter2007-09-25
Letter2008-05-21
Letter2013-07-26
Letter2013-07-26
Letter2014-03-11
Letter2014-11-03
Letter2014-08-11
Label2007-09-19
Label2012-12-07
Label2013-07-30
Label2014-03-10
Label2014-11-04
Label2016-04-27
Review2008-02-22
Other Important Information from FDA2007-03-28
Letter2007-09-25
Letter2015-03-12
Letter2016-04-25
Label2006-08-04
Label2007-09-19
Label2013-07-30
Label2015-03-12
Label2014-08-08
Letter2016-10-28
Label2016-11-01
Label2017-04-25
Letter2017-04-27
Label2017-10-25
Letter2017-10-30
Label2019-10-24
Letter2019-10-24
Letter2020-10-01
Label2020-10-02
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01

Application Sponsors

NDA 021872UCB INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS500MG/5ML (100MG/ML)1KEPPRALEVETIRACETAM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2006-07-31STANDARD
LABELING; LabelingSUPPL2AP2007-09-12STANDARD
EFFICACY; EfficacySUPPL3AP2007-09-12UNKNOWN
EFFICACY; EfficacySUPPL5AP2008-05-16STANDARD
LABELING; LabelingSUPPL12AP2013-07-25UNKNOWN
LABELING; LabelingSUPPL13AP2013-07-25STANDARD
LABELING; LabelingSUPPL15AP2014-03-07STANDARD
EFFICACY; EfficacySUPPL16AP2014-10-30STANDARD
LABELING; LabelingSUPPL17AP2015-03-10STANDARD
LABELING; LabelingSUPPL18AP2014-08-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2015-08-14STANDARD
LABELING; LabelingSUPPL21AP2016-04-06STANDARD
LABELING; LabelingSUPPL22AP2016-10-26STANDARD
LABELING; LabelingSUPPL23AP2017-04-24STANDARD
LABELING; LabelingSUPPL24AP2017-10-24STANDARD
EFFICACY; EfficacySUPPL28AP2019-10-23STANDARD
LABELING; LabelingSUPPL29AP2020-09-30STANDARD

Submissions Property Types

SUPPL12Null7
SUPPL13Null7
SUPPL15Null7
SUPPL16Null7
SUPPL17Null15
SUPPL18Null6
SUPPL19Null0
SUPPL21Null7
SUPPL22Null15
SUPPL23Null6
SUPPL24Null6
SUPPL28Null7
SUPPL29Null7

TE Codes

001PrescriptionAP

CDER Filings

UCB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21872
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KEPPRA","activeIngredients":"LEVETIRACETAM","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/23\/2019","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021872s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021872s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021872s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021872s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021872s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021872s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021872s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021872s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2014","submission":"SUPPL-16","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021872s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021872s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021872s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021872s012s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021872s012s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2008","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021872s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2007","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021872s002s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2007","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021872s002s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021872lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KEPPRA","submission":"LEVETIRACETAM","actionType":"500MG\/5ML (100MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-23
        )

)
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