FDA.reportPublic FDA data

Application 050592

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRADEXDEXAMETHASONE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.1%;0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0647TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0647TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0647TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0647TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0647TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0647TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0078-0953TobraDextobramycin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
21695-203TobraDextobramycin and dexamethasoneRebel Distributors CorpNDACurrent
21695-416Tobramycin and DexamethasoneTobramycin and DexamethasoneRebel Distributors CorpNDACurrent
50090-1135Tobramycin and DexamethasoneTobramycin and DexamethasoneA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
52959-984Tobramycin and DexamethasoneTobramycin and DexamethasoneH.J. Harkins Company, Inc.NDA AUTHORIZED GENERICCurrent
61314-647Tobramycin and DexamethasoneTobramycin and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
61314-647Tobramycin and DexamethasoneTobramycin and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
61314-647Tobramycin and DexamethasoneTobramycin and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
61314-647Tobramycin and DexamethasoneTobramycin and DexamethasoneSandoz Inc.NDA AUTHORIZED GENERICCurrent
61314-647Tobramycin and DexamethasoneTobramycin and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85681SUPPL 2026-04-14
85680SUPPL 2026-04-14
67518SUPPL2021-05-17
67517SUPPL2021-05-17
67504SUPPL2021-05-17
67503SUPPL2021-05-17
62708SUPPL2020-04-28
62696SUPPL2020-04-28
17913SUPPL2003-07-08
7863SUPPL2003-07-06