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General MedicationsINTRAVENOUSStandard

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

NICARDIPINE HYDROCHLORIDE

Standard Dose
20MG/200ML (0.1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is listed in Drugs@FDA under application 019734 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NICARDIPINE HYDROCHLORIDE Form and strength INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML) Sponsor CHIESI Submission history Latest submission status date: 2026-03-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is listed in Drugs@FDA under application 019734 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NICARDIPINE HYDROCHLORIDE Form and strength INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML) Sponsor CHIESI Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.