General MedicationsORALGeneric

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Standard Dose

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL is listed in Drugs@FDA under application 202217 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Form and strength FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL - 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM Sponsor NOVEL LABS INC Submission history Latest submission status date: 2021-05-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL is listed in Drugs@FDA under application 202217 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Form and strength FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL - 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM Sponsor NOVEL LABS INC Submission history Latest submission status date: 2021-05-14 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.