BOEHRINGER INGELHEIM FDA Approval NDA 022421

NDA 022421

BOEHRINGER INGELHEIM

FDA Drug Application

Application #022421

Documents

Letter2010-02-26
Letter2010-07-15
Letter2012-09-05
Letter2015-04-01
Letter2016-01-15
Letter2016-08-01
Label2014-05-12
Label2012-09-06
Label2016-01-15
Summary Review2010-08-20
Letter2014-05-09
Letter2013-03-04
Label2010-02-25
Label2010-07-22
Label2013-03-05
Label2015-04-02
Label2016-08-02
Review2010-08-20
Other Important Information from FDA2012-09-19
Label2018-05-11
Letter2018-05-15
Letter2020-01-30
Label2020-08-04
Letter2021-07-14
Label2021-07-14

Application Sponsors

NDA 022421BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET, EXTENDED RELEASE;ORAL0.375MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL0.75MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL1.5MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL3MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORAL4.5MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE
006TABLET, EXTENDED RELEASE;ORAL2.25MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE
007TABLET, EXTENDED RELEASE;ORAL3.75MG1MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2010-02-19STANDARD
LABELING; LabelingSUPPL3AP2014-05-08STANDARD
EFFICACY; EfficacySUPPL6AP2012-08-31STANDARD
LABELING; LabelingSUPPL7AP2013-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-07-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2013-08-23STANDARD
LABELING; LabelingSUPPL10AP2015-03-27STANDARD
LABELING; LabelingSUPPL13AP2016-01-14STANDARD
LABELING; LabelingSUPPL14AP2016-07-28STANDARD
LABELING; LabelingSUPPL17AP2018-05-10STANDARD
LABELING; LabelingSUPPL20AP2020-01-30STANDARD
LABELING; LabelingSUPPL22AP2021-07-12STANDARD

Submissions Property Types

ORIG1Null6
SUPPL3Null15
SUPPL6Null6
SUPPL7Null7
SUPPL8Null0
SUPPL9Null0
SUPPL10Null15
SUPPL13Null7
SUPPL14Null15
SUPPL17Null7
SUPPL20Null15
SUPPL22Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22421
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.375MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"4.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"2.25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX ER","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"3.75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022421Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022421Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022421s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022421s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022421s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022421s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022421s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022421s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2012","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022421s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022421s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022421lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.375MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.75MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"3MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"4.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"2.25MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX ER","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"3.75MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-01-30
        )

)
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