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General MedicationsINTRAVENOUSStandard

SODIUM PHOSPHATES

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Standard Dose
13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SODIUM PHOSPHATES is listed in Drugs@FDA under application 218314 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE Form and strength SOLUTION;INTRAVENOUS - 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) Sponsor AM REGENT Submission history Latest submission status date: 2024-06-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview SODIUM PHOSPHATES is listed in Drugs@FDA under application 218314 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE Form and strength SOLUTION;INTRAVENOUS - 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) Sponsor AM REGENT Submission history Latest submission status date: 2024-06-21 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.