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General MedicationsORALGeneric

COTAZYM

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

Standard Dose
30,000USP UNITS;8,000USP UNITS;30,000USP UNITS
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview COTAZYM is listed in Drugs@FDA under application 020580 (BLA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) Form and strength CAPSULE;ORAL - 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS Sponsor ORGANON USA INC Submission history Latest submission status date: 2000-10-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview COTAZYM is listed in Drugs@FDA under application 020580 (BLA). Review priority: STANDARD Marketing status: Discontinued Active ingredient PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) Form and strength CAPSULE;ORAL - 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS Sponsor ORGANON USA INC Submission history Latest submission status date: 2000-10-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.