FDA.reportPublic FDA data

Application 050541

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBREXTOBRAMYCINSOLUTION/DROPS;OPHTHALMIC0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0643TobrextobramycinAlcon Laboratories, Inc.NDACurrent
0065-0643TobrextobramycinAlcon Laboratories, Inc.NDACurrent
0065-0643TobrextobramycinAlcon Laboratories, Inc.NDACurrent
0065-0643TobrextobramycinAlcon Laboratories, Inc.NDACurrent
0065-0643TobrextobramycinAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67515SUPPL2021-05-17
67500SUPPL2021-05-17
62695SUPPL2020-04-28
62693SUPPL2020-04-27
17861SUPPL2013-01-02
30062SUPPL2012-12-19
38969SUPPL2003-07-28
7797SUPPL2003-07-28