General MedicationsORALStandard

ZENPEP

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

Standard Dose

168,000USP UNITS;40,000USP UNITS;126,000USP UNITS

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ZENPEP is listed in Drugs@FDA under application 022210 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) Form and strength CAPSULE, DELAYED RELEASE;ORAL - 168,000USP UNITS;40,000USP UNITS;126,000USP UNITS Sponsor EURAND PHARMA LTD Submission history Latest submission status date: 2024-02-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZENPEP is listed in Drugs@FDA under application 022210 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) Form and strength CAPSULE, DELAYED RELEASE;ORAL - 168,000USP UNITS;40,000USP UNITS;126,000USP UNITS Sponsor EURAND PHARMA LTD Submission history Latest submission status date: 2024-02-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.