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General MedicationsORALGeneric

EPANOVA

OMEGA-3-CARBOXYLIC ACIDS

Standard Dose
1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview EPANOVA is listed in Drugs@FDA under application 205060 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient OMEGA-3-CARBOXYLIC ACIDS Form and strength CAPSULE;ORAL - 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS Sponsor ASTRAZENECA Submission history Latest submission status date: 2017-03-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview EPANOVA is listed in Drugs@FDA under application 205060 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient OMEGA-3-CARBOXYLIC ACIDS Form and strength CAPSULE;ORAL - 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS Sponsor ASTRAZENECA Submission history Latest submission status date: 2017-03-09 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
EPANOVA (OMEGA-3-CARBOXYLIC ACIDS) | Drug Monograph | MedicHelpline