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FDA NDA · NDA020664

CABERGOLINE

Sponsor: PFIZER

APPLICATION
NDA020664
TYPE
NDA
ORIGINAL APPROVAL
1996-12-23
LATEST ACTION
2025-04-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DOSTINEX · ReferenceDiscontinued
CABERGOLINE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-04-21Labeling · Supplement 16 · unknown — Letter ↗AP
2019-12-13Labeling · Supplement 17 · standard — Label ↗AP
2014-08-29Manufacturing (CMC) · Supplement 15 · standardAP
2014-08-26Labeling · Supplement 13 · standard — Letter ↗AP
2014-05-30Manufacturing (CMC) · Supplement 14 · standardAP
2011-08-11Efficacy · Supplement 12 · standard — Label ↗AP
2011-07-18Labeling · Supplement 11 · unknown — Label ↗AP
2007-12-19Labeling · Supplement 10 · standard — Letter ↗AP
2007-02-09Manufacturing (CMC) · Supplement 7 · standard — Label ↗AP
2006-12-12Labeling · Supplement 8 · standard — Letter ↗AP
2000-04-17Labeling · Supplement 4 · standardAP
1998-05-15Manufacturing (CMC) · Supplement 3 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 2 · standardAP
1996-12-23Type 1 - New Molecular Entity · Original · standard — Review ↗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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