Application 020667

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.125MG	Yes	No
002	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.25MG	Yes	Yes
003	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1MG	Yes	No
004	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.25MG	No	No
005	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.5MG	Yes	No
006	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.5MG	Yes	No
007	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.75MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0184	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0184	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0184	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
21695-867	Mirapex	pramipexole dihydrochloride	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68090	SUPPL	2021-07-14
68073	SUPPL	2021-07-14
65361	SUPPL	2020-11-30
62507	SUPPL	2020-04-08
62451	SUPPL	2020-04-06
61740	SUPPL	2020-01-30
54287	ORIG	2018-05-22
54193	SUPPL	2018-05-15
54142	SUPPL	2018-05-11
13176	SUPPL	2016-08-02
3046	SUPPL	2016-08-01
13175	SUPPL	2016-01-25
25482	SUPPL	2016-01-15
3045	SUPPL	2015-04-03
35118	SUPPL	2015-04-02
13174	SUPPL	2015-04-02
25481	SUPPL	2015-03-31
35117	SUPPL	2013-03-05
3044	SUPPL	2013-03-04
44065	ORIG	2012-09-19
35116	SUPPL	2012-09-06
25480	SUPPL	2012-09-05
13170	SUPPL	2012-07-30
35115	SUPPL	2012-07-19
35114	SUPPL	2012-07-19
13172	SUPPL	2012-07-19
13171	SUPPL	2012-07-19
25478	SUPPL	2012-07-18
25477	SUPPL	2012-07-18
3043	SUPPL	2012-07-18
3042	SUPPL	2012-07-18
3041	SUPPL	2012-07-18
25479	SUPPL	2011-05-16
13173	SUPPL	2011-05-16
35113	SUPPL	2009-01-06
25476	SUPPL	2009-01-06
13169	SUPPL	2009-01-06
12954	SUPPL	2009-01-06
3040	SUPPL	2009-01-06
3039	SUPPL	2009-01-06
20809	SUPPL	2007-06-12
25475	SUPPL	2006-11-14
25474	SUPPL	2006-11-14
35112	SUPPL	2006-11-09
12953	SUPPL	2006-11-09
25473	SUPPL	2003-05-30
41534	ORIG	1997-07-01
3038	ORIG	1997-07-01

Application 020667

Related Records#

Application Products#

NDC Listings For This Application#

Documents#