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General MedicationsINJECTIONGeneric

AMINOSYN II 3.5% M

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Standard Dose
3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview AMINOSYN II 3.5% M is listed in Drugs@FDA under application 019437 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE Form and strength INJECTABLE;INJECTION - 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML Sponsor ICU MEDICAL INC Submission history Latest submission status date: 2016-06-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMINOSYN II 3.5% M is listed in Drugs@FDA under application 019437 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE Form and strength INJECTABLE;INJECTION - 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML Sponsor ICU MEDICAL INC Submission history Latest submission status date: 2016-06-06 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
AMINOSYN II 3.5% M (AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) | Drug Monograph | MedicHelpline