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General MedicationsORALStandard

ZENPEP

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

Standard Dose
14,000USP UNITS;3,000USP UNITS;10,000USP 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 - 14,000USP UNITS;3,000USP UNITS;10,000USP 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 - 14,000USP UNITS;3,000USP UNITS;10,000USP 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.