Documents
Application Sponsors
| NDA 020667 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Discontinued | 004 |
| Prescription | 005 |
| Prescription | 006 |
| Prescription | 007 |
Application Products
| 001 | TABLET;ORAL | 0.125MG | 1 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
| 002 | TABLET;ORAL | 0.25MG | 1 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
| 003 | TABLET;ORAL | 1MG | 1 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
| 004 | TABLET;ORAL | 1.25MG | 0 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
| 005 | TABLET;ORAL | 1.5MG | 1 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
| 006 | TABLET;ORAL | 0.5MG | 1 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
| 007 | TABLET;ORAL | 0.75MG | 1 | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1997-07-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-02-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1999-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2003-05-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-12-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2006-11-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2006-11-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 2008-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2008-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2008-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2012-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2012-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2012-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2012-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2012-07-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2011-05-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2012-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2013-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2015-03-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-05-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2015-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2016-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2016-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2018-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2020-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2020-04-03 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 44 | AP | 2021-07-12 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 44 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
| 007 | Prescription | AB |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 20667
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MIRAPEX","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/03\/2020","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020667s041lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020667Orig1s039lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020667Orig1s039lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2018","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020667s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020667s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2016","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020667s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020667s030lbledt.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020667s030lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2013","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020667s029lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2012","submission":"SUPPL-27","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020667s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020667s019s021s022s023s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020667s019s021s022s023s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020667s019s021s022s023s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020667s019s021s022s023s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2012","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020667s019s021s022s023s024lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2011","submission":"SUPPL-25","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020667s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020667s014s017s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020667s014s017s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020667s014s017s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2006","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020667s011s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2006","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020667s011s013lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MIRAPEX","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-04-03
)
)