FDA.reportPublic FDA data

Application 050616

Type
NDA
Sponsor
NOVARTIS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0648TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0648TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0648TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0648TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-0648TobraDextobramycin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0078-0876TobraDextobramycin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0876TobraDextobramycin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0876TobraDextobramycin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
21695-628TobraDextobramycin and dexamethasoneRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73670SUPPL 2023-03-03
73522SUPPL 2023-02-16
73521SUPPL 2023-02-16
73520SUPPL 2023-02-16
73519SUPPL 2023-02-16
73518SUPPL 2023-02-16
73517SUPPL 2023-02-16
73516SUPPL 2023-02-16
73515SUPPL 2023-02-16
73514SUPPL 2023-02-16
73513SUPPL 2023-02-16
67538SUPPL2021-05-18
67537SUPPL2021-05-18
67506SUPPL2021-05-17
67505SUPPL2021-05-17
62709SUPPL2020-04-28
62697SUPPL2020-04-28
39045SUPPL2004-07-21
30176SUPPL2004-07-21
17934SUPPL2004-07-21
7891SUPPL2004-07-21
39044SUPPL2004-06-28
39043SUPPL2004-06-28
30174SUPPL2004-06-28
7890SUPPL2004-06-28
22168SUPPL2003-09-11
30175SUPPL2003-03-26
17933SUPPL2003-03-26