FDA.reportPublic FDA data

Application 013422

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAXIDEXDEXAMETHASONESUSPENSION/DROPS;OPHTHALMIC0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0925MaxidexdexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0998-0615MaxidexdexamethasoneAlcon Laboratories, Inc.NDACurrent
0998-0615MaxidexdexamethasoneAlcon Laboratories, Inc.NDACurrent
0998-0615MaxidexdexamethasoneAlcon Laboratories, Inc.NDACurrent
0998-0615MaxidexdexamethasoneAlcon Laboratories, Inc.NDACurrent
0998-0615MaxidexdexamethasoneAlcon Laboratories, Inc.NDACurrent
0998-0615MaxidexdexamethasoneAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69557SUPPL2021-12-15
69549SUPPL2021-12-14
67498SUPPL2021-05-17
67491SUPPL2021-05-17
50357SUPPL2017-11-09
50324SUPPL2017-11-07
364SUPPL2003-05-29
33107SUPPL2003-05-28