General MedicationsORALStandard

OMEGA-3-ACID ETHYL ESTERS

Standard Dose

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview OMEGA-3-ACID ETHYL ESTERS is listed in Drugs@FDA under application 215458 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OMEGA-3-ACID ETHYL ESTERS Form and strength CAPSULE;ORAL - 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Sponsor MANKIND PHARMA Submission history Latest submission status date: 2021-11-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview OMEGA-3-ACID ETHYL ESTERS is listed in Drugs@FDA under application 215458 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMEGA-3-ACID ETHYL ESTERS Form and strength CAPSULE;ORAL - 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Sponsor MANKIND PHARMA Submission history Latest submission status date: 2021-11-15 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.