FDA.reportPublic FDA data

Application 208647

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZALLORROSUVASTATIN CALCIUMCAPSULE;ORALEQ 5MG BASEYesNo
002EZALLORROSUVASTATIN CALCIUMCAPSULE;ORALEQ 10MG BASEYesNo
003EZALLORROSUVASTATIN CALCIUMCAPSULE;ORALEQ 20MG BASEYesNo
004EZALLORROSUVASTATIN CALCIUMCAPSULE;ORALEQ 40MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-984EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-984EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-984EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-984EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-985EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-985EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-985EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-985EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-986EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-986EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-986EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-986EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-987EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-987EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-987EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent
47335-987EZALLOR SPRINKLEROSUVASTATINSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81254SUPPL 2025-02-14
81238SUPPL 2025-02-13
77909SUPPL 2024-03-21
77897SUPPL 2024-03-21
75018SUPPL 2023-08-07
75017SUPPL 2023-08-07
75016SUPPL 2023-08-07
75015SUPPL 2023-08-07
75014SUPPL 2023-08-07
75013SUPPL 2023-08-07
75008SUPPL 2023-08-07
75007SUPPL 2023-08-07
75006SUPPL 2023-08-07
75005SUPPL 2023-08-07
75004SUPPL 2023-08-07
75003SUPPL 2023-08-07
64721SUPPL2020-09-29
64708SUPPL2020-09-28
62608SUPPL2020-04-20
62598SUPPL2020-04-20
59643ORIG2019-08-09
58192SUPPL2019-04-02
58135SUPPL2019-03-29
56935ORIG2018-12-21
56799ORIG2018-12-19