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General MedicationsINTRAVENOUSStandard

DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

DILTIAZEM HYDROCHLORIDE

Standard Dose
100MG/100ML (1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is listed in Drugs@FDA under application 218038 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 100MG/100ML (1MG/ML) Sponsor HQ SPCLT PHARMA Submission history Latest submission status date: 2025-02-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is listed in Drugs@FDA under application 218038 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 100MG/100ML (1MG/ML) Sponsor HQ SPCLT PHARMA Submission history Latest submission status date: 2025-02-21 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE (DILTIAZEM HYDROCHLORIDE) | Drug Monograph | MedicHelpline