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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050616-001TOBRADEXDEXAMETHASONE; TOBRAMYCIN0.1%;0.3%OINTMENT / OPHTHALMICRLD, RS1988-09-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050616-001TOBRADEX0.1%;0.3%OINTMENT / OPHTHALMICRLD, RS1988-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050616-001TOBRADEX0.1%;0.3%OINTMENT / OPHTHALMICRLD, RS1988-09-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050616-001TOBRADEX0.1%;0.3%OINTMENT / OPHTHALMICRLD, RS1988-09-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050616-001TOBRADEX0.1%;0.3%OINTMENT / OPHTHALMICRLD, RS1988-09-28a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TobraDexTOBRAMYCIN AND DEXAMETHASONENovartis Pharmaceuticals Corporation7f310e0e-0d3b-493d-b6c4-238493a2a9b92026-07-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 050616
application number: NDA050616
ndc (product): 0078-0876

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

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