General MedicationsTABLETGeneric

BEMPEDOIC ACID AND EZETIMIBE

BEMPEDOIC ACID, EZETIMIBE

Standard Dose

180MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview BEMPEDOIC ACID AND EZETIMIBE is listed in Drugs@FDA under application 219421 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BEMPEDOIC ACID, EZETIMIBE Form and strength TABLET - 180MG Sponsor ALKEM LABORATORIES LIMITED Submission history Latest submission status date: 2025-10-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview BEMPEDOIC ACID AND EZETIMIBE is listed in Drugs@FDA under application 219421 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BEMPEDOIC ACID, EZETIMIBE Form and strength TABLET - 180MG Sponsor ALKEM LABORATORIES LIMITED Submission history Latest submission status date: 2025-10-23 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.