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General MedicationsORALGeneric

ENTEREG

ALVIMOPAN

Standard Dose
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Discontinued
Summary

Approval overview ENTEREG is listed in Drugs@FDA under application 021775 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient ALVIMOPAN Form and strength CAPSULE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CUBIST PHARMS Submission history Latest submission status date: 2023-06-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview ENTEREG is listed in Drugs@FDA under application 021775 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient ALVIMOPAN Form and strength CAPSULE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CUBIST PHARMS Submission history Latest submission status date: 2023-06-12 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.