FDA.reportPublic FDA data

Application 050450

Type
NDA
Sponsor
BRISTOL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MUTAMYCINMITOMYCININJECTABLE;INJECTION5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002MUTAMYCINMITOMYCININJECTABLE;INJECTION20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050450-001MUTAMYCINMITOMYCIN5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N050450-002MUTAMYCINMITOMYCIN20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050450-001MUTAMYCIN5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N050450-002MUTAMYCIN20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050450-001MUTAMYCIN5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N050450-002MUTAMYCIN20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050450-001MUTAMYCIN5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050450-002MUTAMYCIN20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050450-001MUTAMYCIN5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050450-002MUTAMYCIN20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MitomycinMITOMYCINHikma Pharmaceuticals USA Inc.5917f7a7-cd20-407b-8dda-9fd58c5f47a62026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINBryant Ranch Prepack5f41676f-f687-47db-871c-35bbf2447a982025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
JELMYTOMITOMYCINUroGen Pharma, Inc.3d3d5053-5427-4a68-a40b-edb60699521e2025-07-09Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
ZUSDURIMITOMYCINUroGen Pharma, Inc8dc68793-bca8-4e3d-b672-622961b582552025-06-20Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitosolMITOMYCINMobius Therapeutics LLC244002c6-c61d-43fe-9326-0727971139792025-04-23Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINAccord Healthcare, Inc.ff676355-313d-4575-8f2f-e4a1e95274772025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MUTAMYCINMITOMYCINAccord BioPharma Inc.cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e2025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MUTAMYCIN
generic name: MITOMYCIN
MitomycinMITOMYCINBryant Ranch Prepack799a06b1-7697-42a3-b31a-c9d621b34f6f2025-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINBluePoint Laboratories57129df7-d6b1-419e-90ec-54f9b5182e7c2024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINEugia US LLCf5a010cf-5954-4e6d-acfa-fb414efdf4712023-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINArchis Pharma LLCcef5026c-8bc3-4428-a178-6effff4dcb3f2023-09-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINArchis Pharma LLC2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f2023-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINSagent Pharmaceuticals10c41a58-c305-4240-80d2-caa0704126482023-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINSagent Pharmaceuticals0171a1c8-c474-4ec1-a11d-6b93a21ca4602023-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINFresenius Kabi USA, LLCbc937e3d-7167-49a5-b6b1-004b0f89d8c42023-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINFresenius Kabi USA, LLC6a4fbc96-e35d-41c2-91fc-4b48220bdba22023-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINGland Pharma Limited2528999b-9f09-4e64-89fc-1e3d69c2d0b62022-11-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINHikma Pharmaceuticals USA Inc.fde1e4e9-fc67-4e84-aa31-0cf0e73e19a82022-09-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINMeitheal Pharmaceuticals Inc.9dd0e3f2-0938-4c57-8d09-040b5405b44f2022-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINGland Pharma Limited650d3024-b9a9-4018-8115-0951acfe31452021-10-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN

Reported adverse events (FAERS/openFDA)#

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