General MedicationsORALGeneric

GOLYTELY

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

Standard Dose

227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview GOLYTELY is listed in Drugs@FDA under application 019011 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS Form and strength FOR SOLUTION;ORAL - 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Sponsor AZURITY Submission history Latest submission status date: 2021-05-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview GOLYTELY is listed in Drugs@FDA under application 019011 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS Form and strength FOR SOLUTION;ORAL - 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Sponsor AZURITY 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.