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General MedicationsORALStandard

OMACOR

OMEGA-3ACID ETHYL ESTERS

Standard Dose
1G
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OMACOR is listed in Drugs@FDA under application 021853 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OMEGA-3ACID ETHYL ESTERS Form and strength CAPSULE; ORAL - 1G Sponsor RELIANT PHARMS Submission history Latest submission status date: 2007-06-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview OMACOR is listed in Drugs@FDA under application 021853 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMEGA-3ACID ETHYL ESTERS Form and strength CAPSULE; ORAL - 1G Sponsor RELIANT PHARMS Submission history Latest submission status date: 2007-06-12 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.