FDA.reportPublic FDA data

Application 207420

Type
ANDA
Sponsor
ASCENT PHARMS 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
31722-936Omega-3-acid ethyl estersOmega-3-acid ethyl estersCamber Pharmaceuticals, Inc.ANDACurrent
31722-936Omega-3-acid ethyl estersOmega-3-acid ethyl estersCamber Pharmaceuticals, Inc.ANDACurrent
31722-936Omega-3-acid ethyl estersOmega-3-acid ethyl estersCamber Pharmaceuticals Inc.ANDACurrent
50090-5799Omega-3-acid ethyl estersOmega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
63629-1918Omega-3-acid ethyl estersOmega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
63629-1918Omega-3-acid ethyl estersOmega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
63629-1918Omega-3-acid ethyl estersOmega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
72865-139Omega-3-acid ethyl estersOmega-3-acid ethyl estersXLCare Pharmaceuticals, Inc.ANDACurrent
72865-139Omega-3-acid ethyl estersOmega-3-acid ethyl estersXLCare Pharmaceuticals, Inc.ANDACurrent
72865-139OMEGA-3-ACID ETHYL ESTERSomega-3-acid ethyl estersXLCare Pharmaceuticals IncANDACurrent