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FDA ANDA · ANDA207058

DOFETILIDE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA207058
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-06
LATEST ACTION
2025-02-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DOFETILIDEPrescription
DOFETILIDE 0.25MG · CAPSULE · ORAL
DOFETILIDEPrescription
DOFETILIDE 0.5MG · CAPSULE · ORAL
DOFETILIDEPrescription
DOFETILIDE 0.125MG · CAPSULE · ORAL

Approval history

2025-02-24Labeling · Supplement 2 · standardAP
2016-06-06UNKNOWN · Original · standard — Label ↗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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