FDA.reportPublic FDA data

Application 211929

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTIKOSBUDESONIDECAPSULE, EXTENDED RELEASE;ORAL6MGYesNo
002ORTIKOSBUDESONIDECAPSULE, EXTENDED RELEASE;ORAL9MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-1002BudesonideBudesonideFERRING PHARMACEUTICALS INC.NDACurrent
55566-1002OrtikosBudesonideFerring Pharmaceuticals Inc.NDACurrent
55566-1002OrtikosBudesonideFerring Pharmaceuticals Inc.NDACurrent
55566-1002OrtikosBudesonideFerring Pharmaceuticals Inc.NDACurrent
55566-1020BudesonideBudesonideFERRING PHARMACEUTICALS INC.NDACurrent
55566-1020OrtikosBudesonideFerring Pharmaceuticals Inc.NDACurrent
55566-1020OrtikosBudesonideFerring Pharmaceuticals Inc.NDACurrent
55566-1020OrtikosBudesonideFerring Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78728SUPPL 2024-07-02
78662SUPPL 2024-06-06
61639ORIG2020-01-24
59092ORIG2019-06-17
59069ORIG2019-06-14