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General MedicationsORALStandard

SUFLAVE

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE

Standard Dose
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SUFLAVE is listed in Drugs@FDA under application 215344 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE Form and strength FOR SOLUTION;ORAL - 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT Sponsor AZURITY Submission history Latest submission status date: 2023-06-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUFLAVE is listed in Drugs@FDA under application 215344 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE Form and strength FOR SOLUTION;ORAL - 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT Sponsor AZURITY Submission history Latest submission status date: 2023-06-15 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.