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FDA ANDA · ANDA077750

CABERGOLINE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA077750
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-07
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CABERGOLINEPrescription
CABERGOLINE 0.5MG · TABLET · ORAL

Approval history

2023-06-28Labeling · Supplement 11 · standardAP
2019-12-13Labeling · Supplement 10 · standardAP
2011-10-26Labeling · Supplement 5AP
2011-10-26Labeling · Supplement 6AP
2008-03-12Labeling · Supplement 2AP
2007-10-01Labeling · Supplement 1AP
2007-03-07OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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