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General MedicationsORALStandard

PLENVU

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Standard Dose
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PLENVU is listed in Drugs@FDA under application 209381 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE Form and strength FOR SOLUTION;ORAL - 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM Sponsor SALIX Submission history Latest submission status date: 2023-09-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview PLENVU is listed in Drugs@FDA under application 209381 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE Form and strength FOR SOLUTION;ORAL - 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM Sponsor SALIX Submission history Latest submission status date: 2023-09-08 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.