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FDA NDA · NDA020667

MIRAPEX

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020667
TYPE
NDA
ORIGINAL APPROVAL
1997-07-01
LATEST ACTION
2021-07-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MIRAPEX · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MIRAPEX · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MIRAPEXDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1.25MG · TABLET · ORAL
MIRAPEX · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MIRAPEX · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MIRAPEX · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MIRAPEX · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-07-12Labeling · Supplement 44 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 41 · 901 required — Letter ↗AP
2020-01-30Labeling · Supplement 39 · standard — Letter ↗AP
2018-05-10Labeling · Supplement 36 · standard — Label ↗AP
2016-07-28Labeling · Supplement 34 · standard — Label ↗AP
2016-01-14Labeling · Supplement 33 · standard — Label ↗AP
2015-11-20Manufacturing (CMC) · Supplement 32 · standardAP
2015-05-11Manufacturing (CMC) · Supplement 31 · standardAP
2015-03-27Labeling · Supplement 30 · standard — Label ↗AP
2013-03-01Labeling · Supplement 29 · standard — Label ↗AP
2012-08-31Efficacy · Supplement 27 · standard — Letter ↗AP
2012-07-17Labeling · Supplement 24 · standard — Label ↗AP
2012-07-17Labeling · Supplement 22 · standard — Label ↗AP
2012-07-17Labeling · Supplement 19 · standard — Label ↗AP
2012-07-17Labeling · Supplement 23 · standard — Letter ↗AP
2012-07-17Labeling · Supplement 21 · standard — Letter ↗AP
2011-05-13Efficacy · Supplement 25 · standard — Label ↗AP
2008-12-31Labeling · Supplement 18 · standard — Label ↗AP
2008-12-31Labeling · Supplement 14 · standard — Label ↗AP
2008-12-31Labeling · Supplement 17 · standard — Label ↗AP
2006-11-07Efficacy · Supplement 13 · unknown — Letter ↗AP
2006-11-07Efficacy · Supplement 11 · standard — Label ↗AP
2003-05-06Labeling · Supplement 8 · standard — Review ↗AP
2002-12-04Manufacturing (CMC) · Supplement 9 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-18Manufacturing (CMC) · Supplement 6 · standardAP
1999-09-03Labeling · Supplement 7 · standardAP
1998-02-19Labeling · Supplement 1 · standardAP
1998-02-12Manufacturing (CMC) · Supplement 2 · standardAP
1997-11-26Manufacturing (CMC) · Supplement 4 · standardAP
1997-07-01Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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