FDA.reportPublic FDA data

Application 050555

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBREXTOBRAMYCINOINTMENT;OPHTHALMIC0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0644TOBREXtobramycinAlcon Laboratories, Inc.NDACurrent
0065-0644TOBREXtobramycinAlcon Laboratories, Inc.NDACurrent
0065-0644TOBREXtobramycinAlcon Laboratories, Inc.NDACurrent
0065-0644TOBREXtobramycinAlcon Laboratories, Inc.NDACurrent
0065-0644TOBREXtobramycinAlcon Laboratories, Inc.NDACurrent
0078-0813TOBREXtobramycinNovartis Pharmaceuticals CorporationNDACurrent
21695-458TobrextobramycinRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67507SUPPL2021-05-17
67502SUPPL2021-05-17
62707SUPPL2020-04-28
62684SUPPL2020-04-27
38979SUPPL2004-07-21
38978SUPPL2004-07-21
30078SUPPL2004-07-21
7814SUPPL2004-07-21
38977SUPPL2003-03-26
38976SUPPL2003-03-26
30077SUPPL2003-03-26
17870SUPPL2003-03-26
7813SUPPL2003-03-26
7812SUPPL2003-03-26