FDA.reportPublic FDA data

Application 210933

Type
NDA
Sponsor
KALA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EYSUVISLOTEPREDNOL ETABONATESOLUTION;OPHTHALMIC0.25%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71571-333Eysuvisloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent
71571-333Eysuvisloteprednol etabonateALCON LABORATORIES, INC.NDACurrent
71571-333Eysuvisloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent
71571-333Eysuvisloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68550ORIG2021-09-08
65122ORIG2020-11-02
65087ORIG2020-10-30