APPLICATION
ANDA078165
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2020-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARVEDILOLPrescription
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 6.25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 3.125MG · TABLET · ORAL
Approval history
2020-03-11Labeling · Supplement 9 · standardAP
2016-04-26Labeling · Supplement 8 · standardAP
2014-09-25Labeling · Supplement 7 · standardAP
2010-02-16Labeling · Supplement 5AP
2007-10-16Labeling · 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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