Application 206665

Type
ANDA
Sponsor
ANCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALISKIREN HEMIFUMARATEALISKIREN HEMIFUMARATETABLET;ORALEQ 150MG BASENoNo
002ALISKIREN HEMIFUMARATEALISKIREN HEMIFUMARATETABLET;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-424ALISKIRENALISKIRENPar Pharmaceutical, Inc.ANDACurrent
49884-425ALISKIRENALISKIRENPar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58403ORIG2019-04-24