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FDA ANDA · ANDA077070

SOTALOL HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA077070
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-04
LATEST ACTION
2005-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL

Approval history

2005-11-04OriginalAP
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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