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General MedicationsSUBCUTANEOUSStandard

GATTEX KIT

TEDUGLUTIDE

Standard Dose
5MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GATTEX KIT is listed in Drugs@FDA under application 203441 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TEDUGLUTIDE Form and strength POWDER;SUBCUTANEOUS - 5MG/VIAL Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2025-09-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview GATTEX KIT is listed in Drugs@FDA under application 203441 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TEDUGLUTIDE Form and strength POWDER;SUBCUTANEOUS - 5MG/VIAL Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2025-09-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
GATTEX KIT (TEDUGLUTIDE) | Drug Monograph | MedicHelpline