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General MedicationsINJECTIONStandard

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

Standard Dose
5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER is listed in Drugs@FDA under application 019513 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS Form and strength INJECTABLE;INJECTION - 5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML Sponsor OTSUKA ICU MEDCL Submission history Latest submission status date: 2013-09-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER is listed in Drugs@FDA under application 019513 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS Form and strength INJECTABLE;INJECTION - 5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML Sponsor OTSUKA ICU MEDCL Submission history Latest submission status date: 2013-09-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.