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FDA ANDA · ANDA204717

CARVEDILOL PHOSPHATE

Sponsor: IMPAX LABS INC

APPLICATION
ANDA204717
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-07
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
CARVEDILOL PHOSPHATEPrescription
CARVEDILOL PHOSPHATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-06-24Labeling · Supplement 6 · standardAP
2018-05-07UNKNOWN · Original · standard — Letter ↗AP
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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