← FDA DRUG APPROVALS

FDA NDA · NDA022012

COREG CR

carvedilol phosphate

Sponsor: WAYLIS THERAP

APPLICATION
NDA022012
TYPE
NDA
ORIGINAL APPROVAL
2006-10-20
LATEST ACTION
2023-07-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

COREG CR · ReferencePrescription
CARVEDILOL PHOSPHATE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
COREG CR · ReferencePrescription
CARVEDILOL PHOSPHATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
COREG CR · ReferencePrescription
CARVEDILOL PHOSPHATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
COREG CR · ReferencePrescription
CARVEDILOL PHOSPHATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-07-26Labeling · Supplement 24 · standard — Letter ↗AP
2017-09-14Labeling · Supplement 22 · standard — Label ↗AP
2015-10-02Labeling · Supplement 21 · standard — Label ↗AP
2011-07-06Labeling · Supplement 20 · unknown — Label ↗AP
2011-01-25Labeling · Supplement 16 · unknown — Label ↗AP
2011-01-06Labeling · Supplement 19 · unknown — Label ↗AP
2011-01-06Labeling · Supplement 17 · unknown — Label ↗AP
2009-06-23Labeling · Supplement 13 · standard — Letter ↗AP
2009-06-23Labeling · Supplement 10 · standard — Label ↗AP
2008-12-19Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · standardAP
2008-12-19Labeling · Supplement 11 · standard — Label ↗AP
2007-10-19Labeling · Supplement 4 · standard — Label ↗AP
2007-08-03Labeling · Supplement 3 · standard — Label ↗AP
2007-07-16Labeling · Supplement 1 · standard — Label ↗AP
2006-10-20Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · standard — Label ↗AP
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