FDA.reportPublic FDA data

Application 211355

Type
ANDA
Sponsor
SOFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSCAPSULE;ORAL1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-410Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersANI Pharmaceuticals, Inc.ANDACurrent
62559-410Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersANI Pharmaceuticals, Inc.ANDACurrent
62559-410Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersANI Pharmaceuticals, Inc.ANDACurrent
62559-410Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersANI Pharmaceuticals, Inc.ANDACurrent