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General MedicationsINJECTIONStandard

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Standard Dose
5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER is listed in Drugs@FDA under application 017610 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE Form and strength INJECTABLE;INJECTION - 5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML Sponsor OTSUKA ICU MEDCL Submission history Latest submission status date: 2014-09-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER is listed in Drugs@FDA under application 017610 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE Form and strength INJECTABLE;INJECTION - 5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML Sponsor OTSUKA ICU MEDCL Submission history Latest submission status date: 2014-09-08 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.