FdaApplication

NDA 204977

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Identifiers

Properties

PropertyValue
applicant_nameOSMOTICA PHARMACEUTICAL US LLC
application_typeNDA
approval_date2014-04-23

Products (1)

ProductActive ingredientStrengthDosage form
OMTRYGOMEGA-3-ACID ETHYL ESTERS TYPE A1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSCAPSULE;ORAL

1 product