APPLICATION
ANDA078251
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2023-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARVEDILOLPrescription
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 3.125MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 6.25MG · TABLET · ORAL
Approval history
2023-11-01Labeling · Supplement 19 · standardAP
2019-03-06Labeling · Supplement 18 · standardAP
2016-03-21Labeling · Supplement 14 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 9AP
2014-09-26Labeling · Supplement 11 · standardAP
2013-05-07Labeling · Supplement 8AP
2013-05-07Labeling · Supplement 10AP
2011-10-21Manufacturing (CMC) · Supplement 6AP
2010-10-15Labeling · Supplement 5AP
2007-11-13Labeling · 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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