FDA.reportPublic FDA data

Application 210565

Type
NDA
Sponsor
KALA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVELTYSLOTEPREDNOL ETABONATESUSPENSION/DROPS;OPHTHALMIC1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71571-121Inveltysloteprednol etabonateALCON LABORATORIES, INC.NDACurrent
71571-121Inveltysloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent
71571-121Inveltysloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent
71571-121Inveltysloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent
71571-121INVELTYSloteprednol etabonateKala Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62700SUPPL2020-04-28
62689SUPPL2020-04-27
57496ORIG2019-02-08
55311ORIG2018-08-24
55271ORIG2018-08-23