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General MedicationsORALGeneric

OMTRYG

OMEGA-3-ACID ETHYL ESTERS TYPE A

Standard Dose
1.2GM 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: Discontinued
Summary

Approval overview OMTRYG is listed in Drugs@FDA under application 204977 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient OMEGA-3-ACID ETHYL ESTERS TYPE A Form and strength CAPSULE;ORAL - 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Sponsor OSMOTICA PHARM US Submission history Latest submission status date: 2025-06-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview OMTRYG is listed in Drugs@FDA under application 204977 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient OMEGA-3-ACID ETHYL ESTERS TYPE A Form and strength CAPSULE;ORAL - 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Sponsor OSMOTICA PHARM US Submission history Latest submission status date: 2025-06-20 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.