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General MedicationsINTRAVENOUSStandard

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

ESMOLOL HYDROCHLORIDE

Standard Dose
2.5GM/250ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is listed in Drugs@FDA under application 205703 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESMOLOL HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 2.5GM/250ML (10MG/ML) Sponsor HQ SPCLT PHARMA Submission history Latest submission status date: 2024-05-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is listed in Drugs@FDA under application 205703 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESMOLOL HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 2.5GM/250ML (10MG/ML) Sponsor HQ SPCLT PHARMA Submission history Latest submission status date: 2024-05-02 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.