FDA.reportPublic FDA data

Application 210093

Type
ANDA
Sponsor
PURACAP PHARM LLC

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
42806-552OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSEPIC PHARMA, LLCANDACurrent
42806-552OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSEPIC PHARMA, LLCANDACurrent
70518-3040OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.ANDACurrent
70518-3040OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.ANDACurrent
71335-2024OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSBryant Ranch PrepackANDACurrent