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General MedicationsORALStandard

SOTYLIZE

SOTALOL HYDROCHLORIDE

Standard Dose
5MG/ML (5MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SOTYLIZE is listed in Drugs@FDA under application 205108 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SOTALOL HYDROCHLORIDE Form and strength SOLUTION;ORAL - 5MG/ML (5MG/ML) Sponsor AZURITY Submission history Latest submission status date: 2024-01-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOTYLIZE is listed in Drugs@FDA under application 205108 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOTALOL HYDROCHLORIDE Form and strength SOLUTION;ORAL - 5MG/ML (5MG/ML) Sponsor AZURITY Submission history Latest submission status date: 2024-01-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.