APPLICATION
ANDA076310
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-29
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CABERGOLINEPrescription
CABERGOLINE 0.5MG · TABLET · ORAL
Approval history
2026-03-18Labeling · Supplement 18 · standardAP
2019-12-13Labeling · Supplement 11 · standardAP
2011-10-26Labeling · Supplement 5AP
2008-06-04Labeling · Supplement 2AP
2007-01-25Labeling · Supplement 1AP
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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