General MedicationsORALStandard

NULYTELY-FLAVORED

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

Standard Dose

420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview NULYTELY-FLAVORED is listed in Drugs@FDA under application 019797 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Form and strength FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Sponsor AZURITY Submission history Latest submission status date: 2021-05-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview NULYTELY-FLAVORED is listed in Drugs@FDA under application 019797 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Form and strength FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Sponsor AZURITY Submission history Latest submission status date: 2021-05-14 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.