FDA.reportPublic FDA data

Application 062336

Type
ANDA
Sponsor
BRISTOL MYERS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MUTAMYCINMITOMYCININJECTABLE;INJECTION5MG/VIALNoNo
002MUTAMYCINMITOMYCININJECTABLE;INJECTION20MG/VIALNoNo
003MUTAMYCINMITOMYCININJECTABLE;INJECTION40MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062336-001MUTAMYCINMITOMYCIN5MG/VIALINJECTABLE / INJECTIONApproved before 1982
A062336-002MUTAMYCINMITOMYCIN20MG/VIALINJECTABLE / INJECTIONApproved before 1982
A062336-003MUTAMYCINMITOMYCIN40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1988-03-10

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A062336-001MUTAMYCIN5MG/VIALINJECTABLE / INJECTIONApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A062336-002MUTAMYCIN20MG/VIALINJECTABLE / INJECTIONApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A062336-003MUTAMYCIN40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1988-03-10a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 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