FDA.reportPublic FDA data

Application 206185

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XELPROSLATANOPROSTEMULSION;OPHTHALMIC0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-317XELPROSlatanoprostSun Pharmaceutical Industries, Inc.NDACurrent
47335-317XELPROSlatanoprostSun Pharmaceutical Industries, Inc.NDACurrent
47335-317XELPROSlatanoprostSun Pharmaceutical Industries, Inc.NDACurrent
47335-317XELPROSlatanprostSun Pharmaceutical Industries, Inc.NDACurrent
47335-317XELPROSlatanoprostSun Pharmaceutical Industries, Inc.NDACurrent
47335-317XELPROSlatanprostSun Pharmaceutical Industries, Inc.NDACurrent
47335-317XELPROSlatanoprostSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79856SUPPL 2024-10-10
79854SUPPL 2024-10-10
79853SUPPL 2024-10-10
65746SUPPL2020-12-28
65708SUPPL2020-12-23
58867ORIG2019-05-28
55483ORIG2018-09-14
55482ORIG2018-09-14