FDA.reportPublic FDA data

Application 209499

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ICOSAPENT ETHYLICOSAPENT ETHYLCAPSULE;ORAL1GMNoNo
002ICOSAPENT ETHYLICOSAPENT ETHYLCAPSULE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-267IcosapentIcosapent EthylDr. Reddy's Laboratories, Inc.ANDACurrent
43598-267IcosapentIcosapent EthylDr. Reddy's Laboratories, Inc.ANDACurrent
63629-9312IcosapentIcosapent EthylBryant Ranch PrepackANDACurrent
63629-9312IcosapentIcosapent EthylBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71964ORIG2022-08-30