FDA.reportPublic FDA data

Application 210913

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEQUACYCLOSPORINESOLUTION;OPHTHALMIC0.09%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-506CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-506CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-506CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-506CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-506CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-506CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-507CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-507CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-507CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-507CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-507CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent
47335-507CEQUAcyclosporineSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60090SUPPL2019-09-23
60087SUPPL2019-09-23
58059ORIG2019-03-21
55212ORIG2018-08-20
55175ORIG2018-08-15