FDA.reportPublic FDA data

Application 022421

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.375MGYesYes
002MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.75MGYesNo
003MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.5MGYesNo
004MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL3MGYesNo
005MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL4.5MGYesNo
006MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.25MGYesNo
007MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL3.75MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0109Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0109Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0109Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0109Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0109Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0113Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0113Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0113Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0113Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0113Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0115Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0115Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0115Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0115Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0115Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0116Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0116Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0116Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0116Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0116Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0285Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0285Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0285Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0285Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0285Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0286Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0286Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0286Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0286Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0286Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0287Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0287Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0287Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0287Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0287Mirapexpramipexole dihydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78753SUPPL 2024-07-02
78776SUPPL 2024-06-12
68087SUPPL2021-07-14
68078SUPPL2021-07-14
64193SUPPL2020-08-04
61741SUPPL2020-01-30
54194SUPPL2018-05-15
54141SUPPL2018-05-11
38690SUPPL2016-08-02
7368SUPPL2016-08-01
17569SUPPL2016-01-15
7367SUPPL2016-01-15
38689SUPPL2015-04-02
7366SUPPL2015-04-01
17567SUPPL2014-05-12
29708SUPPL2014-05-09
38688SUPPL2013-03-05
29709SUPPL2013-03-04
44184ORIG2012-09-19
17568SUPPL2012-09-06
7365SUPPL2012-09-05
42519ORIG2010-08-20
24303ORIG2010-08-20
38687SUPPL2010-07-22
7364SUPPL2010-07-15
7363ORIG2010-02-26
38686ORIG2010-02-25