Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALStandard

MYTESI

CROFELEMER

Standard Dose
125MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MYTESI is listed in Drugs@FDA under application 202292 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CROFELEMER Form and strength TABLET, DELAYED RELEASE;ORAL - 125MG Sponsor NAPO PHARMS INC Submission history Latest submission status date: 2024-04-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview MYTESI is listed in Drugs@FDA under application 202292 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CROFELEMER Form and strength TABLET, DELAYED RELEASE;ORAL - 125MG Sponsor NAPO PHARMS INC Submission history Latest submission status date: 2024-04-03 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.