General MedicationsORALStandard

ICOSAPENT ETHYL

Standard Dose

1GM

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ICOSAPENT ETHYL is listed in Drugs@FDA under application 219156 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ICOSAPENT ETHYL Form and strength CAPSULE;ORAL - 1GM Sponsor XIAMEN LP PHARM CO Submission history Latest submission status date: 2025-08-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview ICOSAPENT ETHYL is listed in Drugs@FDA under application 219156 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ICOSAPENT ETHYL Form and strength CAPSULE;ORAL - 1GM Sponsor XIAMEN LP PHARM CO Submission history Latest submission status date: 2025-08-06 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.