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FDA NDA · NDA022421

MIRAPEX ER

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA022421
TYPE
NDA
ORIGINAL APPROVAL
2010-02-19
LATEST ACTION
2024-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 3MG · TABLET, EXTENDED RELEASE · ORAL
MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET, EXTENDED RELEASE · ORAL
MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG · TABLET, EXTENDED RELEASE · ORAL
MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG · TABLET, EXTENDED RELEASE · ORAL
MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET, EXTENDED RELEASE · ORAL
MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG · TABLET, EXTENDED RELEASE · ORAL
MIRAPEX ER · ReferenceDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-06-07Labeling · Supplement 23 · standard — Letter ↗AP
2021-07-12Labeling · Supplement 22 · standard — Letter ↗AP
2020-01-30Labeling · Supplement 20 · standard — Letter ↗AP
2018-05-10Labeling · Supplement 17 · standard — Label ↗AP
2016-07-28Labeling · Supplement 14 · standard — Label ↗AP
2016-01-14Labeling · Supplement 13 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 10 · standard — Label ↗AP
2014-05-08Labeling · Supplement 3 · standard — Label ↗AP
2013-08-23Manufacturing (CMC) · Supplement 9 · standardAP
2013-07-15Manufacturing (CMC) · Supplement 8 · standardAP
2013-03-01Labeling · Supplement 7 · standard — Label ↗AP
2012-08-31Efficacy · Supplement 6 · standard — Letter ↗AP
2010-07-13Labeling · Supplement 1 · unknown — Label ↗AP
2010-02-19Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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