FDA.reportPublic FDA data

Application 209525

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ICOSAPENT ETHYLICOSAPENT ETHYLCAPSULE;ORAL500MGNoNo
002ICOSAPENT ETHYLICOSAPENT ETHYLCAPSULE;ORAL1GNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0480-0126Icosapent EthylIcosapent EthylTeva Pharmaceuticals, Inc.ANDACurrent
0480-0126Icosapent EthylIcosapent EthylTeva Pharmaceuticals, Inc.ANDACurrent
0480-0127Icosapent EthylIcosapent EthylTeva Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65089ORIG2020-10-30
64401ORIG2020-08-24