General MedicationsINTRAVENOUSStandard

SOTALOL HYDROCHLORIDE

Standard Dose

150MG/10ML (15MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview SOTALOL HYDROCHLORIDE is listed in Drugs@FDA under application 022306 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SOTALOL HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 150MG/10ML (15MG/ML) Sponsor ALTATHERA PHARMS LLC Submission history Latest submission status date: 2025-07-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOTALOL HYDROCHLORIDE is listed in Drugs@FDA under application 022306 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOTALOL HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 150MG/10ML (15MG/ML) Sponsor ALTATHERA PHARMS LLC Submission history Latest submission status date: 2025-07-23 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.