FDA.reportPublic FDA data

Application 216018

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASPRUZYO SPRINKLERANOLAZINEGRANULE;EXTENDED RELEASE500MGNoNo
002ASPRUZYO SPRINKLERANOLAZINEGRANULE;EXTENDED RELEASE1000MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-624ASPRUZYO SPRINKLERanolazineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent
47335-625ASPRUZYO SPRINKLERanolazineSUN PHARMACEUTICAL INDUSTRIES, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72556ORIG2022-11-03
70340ORIG2022-03-01
70316ORIG2022-03-01