FDA.reportPublic FDA data

Application 206455

Type
ANDA
Sponsor
BIONPHARMA INC

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
63629-2448Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
63629-2451Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
63629-2451Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
63629-2451Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
69452-175Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBionpharma Inc.ANDACurrent
69452-175Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBionpharma Inc.ANDACurrent
69452-175Omega-3-Acid Ethyl Esteromega-3-acid ethyl estersBionpharma Inc.ANDACurrent