FDA Approved: SOTALOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

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Summary

FDA approved an original ANDA for sotalol hydrochloride (Sotalol) from Unichem Pharmaceuticals (USA), Inc., enabling generic access to this antiarrhythmic.

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Diseases / indications

• Atrial Fibrillation
• Atrial Flutter
• Ventricular Arrhythmias

Drugs mentioned

• Sotalol hydrochloride (sotalol hydrochloride)

Snippet

ORIG AP for SOTALOL (SOTALOL HYDROCHLORIDE)