UCB INC FDA Approval NDA 022285

NDA 022285

UCB INC

FDA Drug Application

Application #022285

Documents

Letter2008-09-16
Letter2009-02-18
Letter2009-05-04
Letter2009-05-04
Letter2013-07-26
Letter2011-08-12
Letter2014-03-11
Letter2014-03-11
Label2015-03-12
Label2014-08-08
Label2016-04-07
Summary Review2009-01-06
Letter2013-07-26
Letter2015-03-12
Letter2014-08-04
Letter2014-08-11
Letter2016-04-08
Label2008-09-16
Label2009-02-13
Label2009-05-12
Label2009-05-12
Label2013-07-30
Label2013-07-30
Label2014-03-10
Label2014-08-04
Label2014-03-10
Review2009-01-06
Other Important Information from FDA2008-09-19
Letter2016-10-28
Label2016-11-01
Label2017-04-25
Letter2017-04-27
Label2017-10-25
Letter2017-10-30
Pediatric DD Summary Review1900-01-01
Pediatric CDTL Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2019-10-24
Medication Guide2019-10-24
Letter2019-10-24
Letter2020-10-01
Label2020-10-02
Medication Guide2020-10-02

Application Sponsors

NDA 022285UCB INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG1KEPPRA XRLEVETIRACETAM
002TABLET, EXTENDED RELEASE;ORAL750MG1KEPPRA XRLEVETIRACETAM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2008-09-12STANDARD
LABELING; LabelingSUPPL2AP2009-04-23901 REQUIRED
LABELING; LabelingSUPPL3AP2009-04-23STANDARD
LABELING; LabelingSUPPL7AP2009-04-23STANDARD
LABELING; LabelingSUPPL13AP2013-07-25UNKNOWN
REMS; REMSSUPPL14AP2011-08-10N/A
LABELING; LabelingSUPPL15AP2013-07-25STANDARD
LABELING; LabelingSUPPL16AP2014-03-07STANDARD
LABELING; LabelingSUPPL17AP2015-03-10STANDARD
EFFICACY; EfficacySUPPL18AP2014-08-01STANDARD
LABELING; LabelingSUPPL19AP2014-03-07STANDARD
LABELING; LabelingSUPPL20AP2014-08-07STANDARD
LABELING; LabelingSUPPL22AP2016-04-06STANDARD
LABELING; LabelingSUPPL23AP2016-10-26STANDARD
LABELING; LabelingSUPPL25AP2017-04-24STANDARD
LABELING; LabelingSUPPL26AP2017-10-24STANDARD
EFFICACY; EfficacySUPPL28AP2019-10-23STANDARD
LABELING; LabelingSUPPL29AP2020-09-30STANDARD

Submissions Property Types

ORIG1Null6
SUPPL7Null7
SUPPL13Null15
SUPPL14Null15
SUPPL15Null6
SUPPL16Null6
SUPPL17Null7
SUPPL18Null15
SUPPL19Null6
SUPPL20Null6
SUPPL22Null15
SUPPL23Null6
SUPPL25Null15
SUPPL26Null6
SUPPL28Null6
SUPPL29Null6

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

UCB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22285
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022285s028lbl.pdf#page=26"]
            [products] => [{"drugName":"KEPPRA XR","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KEPPRA XR","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","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\\\/022285s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022285s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022285s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022285s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022285s022lbl.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\\\/022285s017lbl.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\\\/022285s017lbl.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\\\/022285s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2014","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022285s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2014","submission":"SUPPL-18","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022285s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022285s016s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022285s016s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022285s013s015lbl.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\\\/022285s013s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022285s002s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-7","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022285s002s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022285s002s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022285s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022285s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022285lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KEPPRA XR","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KEPPRA XR","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-23
        )

)
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