FDA.reportPublic FDA data

Application 210331

Type
NDA
Sponsor
EYEPOINT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YUTIQFLUOCINOLONE ACETONIDEIMPLANT;INTRAVITREAL0.18MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71879-136YUTIQfluocinolone acetonideEyePoint Pharmaceuticals, IncNDACurrent
71879-136YUTIQfluocinolone acetonideEyePoint Pharmaceuticals US, IncNDACurrent
71879-136YUTIQfluocinolone acetonideEyePoint Pharmaceuticals, IncNDACurrent
71879-136YUTIQfluocinolone acetonideEyePoint Pharmaceuticals, IncNDACurrent
71879-136YUTIQfluocinolone acetonideEyePoint Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58213ORIG2019-04-04
55972ORIG2018-10-17