APPLICATION
ANDA090132
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-25
LATEST ACTION
2024-04-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-04-16Labeling · Supplement 2 · standardAP
2024-04-16Labeling · Supplement 5 · standardAP
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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