FDA.reportPublic FDA data

Application 050065

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MAXITROLDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0631MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0631MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0631MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0078-0771MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0771MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0771MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
50090-4435Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
61314-631Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
61314-631Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
61314-631Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
68071-5281Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-5281Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
71205-330Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-330Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and DexamethasoneProficient Rx LPNDA AUTHORIZED GENERICCurrent
72189-038NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDirect_RxNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67536SUPPL2021-05-18
67499SUPPL2021-05-17
50870SUPPL2017-12-27
50761SUPPL2017-12-19
48038SUPPL2017-04-14
48002SUPPL2017-04-13
38911SUPPL2004-07-21
29977SUPPL2004-07-21
17796SUPPL2004-07-21
7690SUPPL2004-07-21
38910SUPPL2003-07-28
29976SUPPL2003-07-28
17795SUPPL2003-07-28
7689SUPPL2003-07-28