FDA.reportPublic FDA data

Application 050818

Type
NDA
Sponsor
EYEVANCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRADEX STDEXAMETHASONE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.05%;0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0652TOBRADEX STtobramycin / dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0652TOBRADEX STtobramycin / dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0652TOBRADEX STtobramycin / dexamethasoneAlcon Laboratories, Inc.NDACurrent
71776-035TobraDex STtobramycin / dexamethasoneEyevance Pharmaceuticals LLCNDACurrent
71776-035TobraDex STtobramycin / dexamethasoneEyevance Pharmaceuticals LLCNDACurrent
71776-035Tobradex STtobramycin / dexamethasoneEyevance Pharmaceuticals, LLCNDACurrent
71776-035Tobradex STtobramycin / dexamethasoneEyevance Pharmaceuticals, LLCNDACurrent
71776-035Tobradex STtobramycin / dexamethasoneEyevance Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85536SUPPL 2026-03-26
71838SUPPL2022-08-17
71837SUPPL2022-08-17
71836SUPPL2022-08-17
71823SUPPL2022-08-17
71822SUPPL2022-08-17
71821SUPPL2022-08-17
18297SUPPL2010-08-10
42753ORIG2010-04-21
24348ORIG2010-04-21
39385ORIG2009-03-02
30608ORIG2009-02-18