General MedicationsINJECTIONStandard

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Standard Dose

N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER is listed in Drugs@FDA under application 021703 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Form and strength INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Sponsor VANTIVE US HLTHCARE Submission history Latest submission status date: 2023-05-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER is listed in Drugs@FDA under application 021703 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Form and strength INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Sponsor VANTIVE US HLTHCARE Submission history Latest submission status date: 2023-05-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.