UCB INC FDA Approval NDA 021829

NDA 021829

UCB INC

FDA Drug Application

Application #021829

Documents

Letter2012-04-04
Label2007-05-10
Label2015-03-02
Review2007-07-02
Patient Package Insert2007-05-10
Letter2007-05-16
Letter2012-04-04
Letter2015-02-27
Label2012-04-02
Label2012-04-02
Review2012-04-02
Review2012-04-02
Label2018-11-30
Letter2018-12-20
Label2019-01-22
Letter2019-01-22
Letter2020-04-06
Label2020-04-27
Letter2020-04-28
Label2020-05-05
Letter2021-07-14
Letter2021-07-14
Label2021-07-14
Label2021-07-14

Application Sponsors

NDA 021829UCB INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL2MG/24HR1NEUPROROTIGOTINE
002FILM, EXTENDED RELEASE;TRANSDERMAL4MG/24HR1NEUPROROTIGOTINE
003FILM, EXTENDED RELEASE;TRANSDERMAL6MG/24HR1NEUPROROTIGOTINE
004FILM, EXTENDED RELEASE;TRANSDERMAL1MG/24HR1NEUPROROTIGOTINE
005FILM, EXTENDED RELEASE;TRANSDERMAL3MG/24HR1NEUPROROTIGOTINE
006FILM, EXTENDED RELEASE;TRANSDERMAL8MG/24HR1NEUPROROTIGOTINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2007-05-09STANDARD
EFFICACY; EfficacySUPPL2AP2012-04-02STANDARD
LABELING; LabelingSUPPL7AP2015-02-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2015-09-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2016-06-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2017-01-30STANDARD
LABELING; LabelingSUPPL15AP2018-11-29STANDARD
LABELING; LabelingSUPPL16AP2019-01-18STANDARD
LABELING; LabelingSUPPL17AP2020-04-24STANDARD
LABELING; LabelingSUPPL19AP2020-04-03901 REQUIRED
LABELING; LabelingSUPPL21AP2021-07-12STANDARD
LABELING; LabelingSUPPL22AP2021-07-12STANDARD

Submissions Property Types

SUPPL1Null6
SUPPL2Null7
SUPPL7Null7
SUPPL9Null0
SUPPL10Null0
SUPPL15Null15
SUPPL16Null15
SUPPL17Null6
SUPPL19Null6
SUPPL21Null15
SUPPL22Null6

CDER Filings

UCB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21829
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEUPRO","activeIngredients":"ROTIGOTINE","strength":"2MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NEUPRO","activeIngredients":"ROTIGOTINE","strength":"4MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NEUPRO","activeIngredients":"ROTIGOTINE","strength":"6MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NEUPRO","activeIngredients":"ROTIGOTINE","strength":"1MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NEUPRO","activeIngredients":"ROTIGOTINE","strength":"3MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NEUPRO","activeIngredients":"ROTIGOTINE","strength":"8MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/24\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021829s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021829s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021829s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021829s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021829s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021829s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021829s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2012","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021829s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021829s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021829lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NEUPRO","submission":"ROTIGOTINE","actionType":"2MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NEUPRO","submission":"ROTIGOTINE","actionType":"4MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NEUPRO","submission":"ROTIGOTINE","actionType":"6MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NEUPRO","submission":"ROTIGOTINE","actionType":"1MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NEUPRO","submission":"ROTIGOTINE","actionType":"3MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NEUPRO","submission":"ROTIGOTINE","actionType":"8MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-24
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.