FDA.reportPublic FDA data

Application 209554

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCINTOBRAMYCINSOLUTION;INHALATION300MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209554-001TOBRAMYCINTOBRAMYCIN300MG/5MLSOLUTION / INHALATION2017-10-13

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A209554-001TOBRAMYCIN300MG/5MLSOLUTION / INHALATION2017-10-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209554-001TOBRAMYCIN300MG/5MLSOLUTION / INHALATION2017-10-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209554-001TOBRAMYCIN300MG/5MLSOLUTION / INHALATION2017-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209554-001AN174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A209554-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A209554-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209554-001AN1ea99ee380514…

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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCINTOBRAMYCINLifestar Pharma LLC5563e8af-c6c9-42a2-974d-7d364a47f00a2026-07-29Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN
generic name: TOBRAMYCIN
TOBRAMYCINTOBRAMYCINNorthStar RxLLC7803ac83-1250-451b-8ad8-2c0a343c30312026-07-29Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINPreferred Pharmaceuticals Inc.417623f1-ed48-41f5-a4b4-6f2e4a23891e2026-07-15Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINSt. Mary's Medical Park Pharmacy9263df93-c558-5d9f-e053-2995a90a546c2026-06-22Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TOBI PodhalerTOBRAMYCINViatris Specialty LLCc4b5bb1f-e158-4ac1-9c35-e98a416c743a2026-04-15Warnings, Adverse reactionsName fallback
generic name: TOBRAMYCIN
TOBRAMYCINTOBRAMYCINHospira, Inc.c5a005b0-7b6f-4e30-df92-9a20b1ca66a12026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINSportpharm LLCe2aa8499-2eab-4ea2-b122-6c7b1ad0c35c2026-03-20Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINXiromed LLC8b50d1b5-ea8a-5844-358a-493f1965c07f2026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
tobramycinTOBRAMYCINSlate Run Pharmaceuticals, LLCed254eec-10f4-425a-895b-66e325b7bf692026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINSportpharm LLC6ded47a3-d5c0-4616-8b7d-d6d0e6bce2a02026-02-05Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINNuCare Pharmaceuticals,Inc.b119bfa5-33b0-84eb-e053-2995a90a2cad2026-02-04Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINJVET PHARMACEUTICALS LLCc6435b8f-bb6e-45e0-a52b-3087fd043b5a2026-01-26Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINREMEDYREPACK INC.3596dacc-6abc-45eb-8085-fa7aaa580a1c2026-01-21Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINAmerican Health Packagingf2f8bf02-57f8-4d34-937a-32411fc6bfba2025-12-22Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TOBREXTOBRAMYCINNovartis Pharmaceuticals Corporation5b66bba3-cf97-4a9c-b618-ba5f277f20f62025-12-16Warnings, Adverse reactionsName fallback
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINRitedose Pharmaceuticals, LLCe8205898-0162-4e6c-bcf1-87cb074ab9ae2025-12-10Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TOBITOBRAMYCINViatris Specialty LLC6a3c3871-1d3a-44d6-8be3-526b30123ef72025-11-15Warnings, Adverse reactionsName fallback
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINXGen Pharmaceuticals DJB, Inc.a384641c-04e3-4ab5-b152-7408cd07b64d2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINNorthstar Rx LLC55d09ffd-4f32-8aeb-3904-8a17db635e3a2025-09-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN
TobramycinTOBRAMYCINSomerset Therapeutics, LLC7333280d-5d2a-4609-ab93-3ab7031b65db2025-07-10Warnings, Adverse reactionsName fallback
brand name: Tobramycin
generic name: TOBRAMYCIN

Reported adverse events (FAERS/openFDA)#

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