FDA Drug Application (090973) for OMEGA-3-ACID ETHYL ESTERS by APOTEX INC

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Application Number090973
Product Number001
FormCAPSULE;ORAL
Dosage1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameOMEGA-3-ACID ETHYL ESTERS
Active IngredientOMEGA-3-ACID ETHYL ESTERS



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