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FDA approval · 2015-11-27

FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (Amneal Pharmaceuticals LLC)

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Summary

FDA approves Amneal's original ANDA for Omega-3-acid ethyl esters (ANDA 204940). This provides a new generic option for the treatment of hypertriglyceridemia.

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Diseases / indications

Drugs mentioned

  • Omega-3-acid ethyl esters (Omega-3-acid ethyl esters)

Snippet

ORIG AP for OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)