FDA.reportPublic FDA data

Application 208912

Type
NDA
Sponsor
EYEPOINT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXYCU KITDEXAMETHASONESUSPENSION;INTRAOCULAR9%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63429SUPPL2020-06-08
63424SUPPL2020-06-05
55861ORIG2018-10-10
52548ORIG2018-02-09
52529ORIG2018-02-09