FDA.reportPublic FDA data

Application 204940

Type
ANDA
Sponsor
AMNEAL 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
16714-660Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersNorthStar Rx LLCANDACurrent
16714-660Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersNorthStar Rx LLCANDACurrent
16714-660Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersNorthStar Rx LLCANDACurrent
17856-0034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersAtlantic Biologicals CorpsANDACurrent
65162-034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersAmneal Pharmaceuticals LLCANDACurrent
65162-034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersAmneal Pharmaceuticals LLCANDACurrent
65162-034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersAmneal Pharmaceuticals LLCANDACurrent
65162-034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersAmneal Pharmaceuticals LLCANDACurrent
69784-420Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersWoodward Pharma Services LLCANDACurrent
69784-420LOVAZAOmega-3-Acid Ethyl EstersWoodward Pharma Services LLCANDACurrent
69784-420LOVAZAOmega-3-Acid Ethyl EstersWoodward Pharma Services LLCANDACurrent
70518-2319Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersREMEDYREPACK INC.ANDACurrent
70518-2319Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersREMEDYREPACK INC.ANDACurrent