FDA.reportPublic FDA data

Application 203893

Type
ANDA
Sponsor
STRIDES PHARMA

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
0254-3010Omega-3-acid ethyl estersOmega-3-acid ethyl estersPar Pharmaceutical Inc.ANDACurrent
50268-676omega-3-acid ethyl estersomega-3-acid ethyl estersAvPAKANDACurrent
50268-676omega-3-acid ethyl estersomega-3-acid ethyl estersAvPAKANDACurrent
64380-761omega-3-acid ethyl estersomega-3-acid ethyl estersStrides Pharma Science LimitedANDACurrent
64380-761omega-3-acid ethyl estersomega-3-acid ethyl estersStrides Pharma Science LimitedANDACurrent
64380-761omega-3-acid ethyl estersomega-3-acid ethyl estersStrides Pharma Science LimitedANDACurrent
64380-761omega-3-acid ethyl estersomega-3-acid ethyl estersStrides Pharma Science LimitedANDACurrent
64380-761omega-3-acid ethyl estersomega-3-acid ethyl estersStrides Pharma Science LimitedANDACurrent