APPLICATION
ANDA077843
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-03
LATEST ACTION
2025-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CABERGOLINEDiscontinued
CABERGOLINE 0.5MG · TABLET · ORAL
Approval history
2025-07-07Labeling · Supplement 5 · standardAP
2019-12-13Labeling · Supplement 4 · standardAP
2008-06-03Labeling · Supplement 1AP
2007-07-03OriginalAP
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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