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General MedicationsORALStandard

LUBIPROSTONE

LUBIPROSTONE

Standard Dose
8MCG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LUBIPROSTONE is listed in Drugs@FDA under application 218640 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LUBIPROSTONE Form and strength CAPSULE;ORAL - 8MCG Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-01-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUBIPROSTONE is listed in Drugs@FDA under application 218640 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LUBIPROSTONE Form and strength CAPSULE;ORAL - 8MCG Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-01-02 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.