Application 050450
- Type
- NDA
- Sponsor
- BRISTOL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MUTAMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | MUTAMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050450-001 | MUTAMYCIN | MITOMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050450-002 | MUTAMYCIN | MITOMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050450-001 | MUTAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050450-002 | MUTAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050450-001 | MUTAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050450-002 | MUTAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050450-001 | MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050450-002 | MUTAMYCIN | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mitomycin | MITOMYCIN | Hikma Pharmaceuticals USA Inc. | 5917f7a7-cd20-407b-8dda-9fd58c5f47a6 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Bryant Ranch Prepack | 5f41676f-f687-47db-871c-35bbf2447a98 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| JELMYTO | MITOMYCIN | UroGen Pharma, Inc. | 3d3d5053-5427-4a68-a40b-edb60699521e | 2025-07-09 | Warnings, Adverse reactions | MITOMYCIN |
| ZUSDURI | MITOMYCIN | UroGen Pharma, Inc | 8dc68793-bca8-4e3d-b672-622961b58255 | 2025-06-20 | Warnings, Adverse reactions | MITOMYCIN |
| Mitosol | MITOMYCIN | Mobius Therapeutics LLC | 244002c6-c61d-43fe-9326-072797113979 | 2025-04-23 | Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Accord Healthcare, Inc. | ff676355-313d-4575-8f2f-e4a1e9527477 | 2025-04-22 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MUTAMYCIN | MITOMYCIN | Accord BioPharma Inc. | cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | MUTAMYCIN MITOMYCIN |
| Mitomycin | MITOMYCIN | Bryant Ranch Prepack | 799a06b1-7697-42a3-b31a-c9d621b34f6f | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | BluePoint Laboratories | 57129df7-d6b1-419e-90ec-54f9b5182e7c | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | Eugia US LLC | f5a010cf-5954-4e6d-acfa-fb414efdf471 | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Archis Pharma LLC | cef5026c-8bc3-4428-a178-6effff4dcb3f | 2023-09-21 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Archis Pharma LLC | 2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f | 2023-06-05 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Sagent Pharmaceuticals | 10c41a58-c305-4240-80d2-caa070412648 | 2023-05-24 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Sagent Pharmaceuticals | 0171a1c8-c474-4ec1-a11d-6b93a21ca460 | 2023-05-24 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | Fresenius Kabi USA, LLC | bc937e3d-7167-49a5-b6b1-004b0f89d8c4 | 2023-01-12 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | Fresenius Kabi USA, LLC | 6a4fbc96-e35d-41c2-91fc-4b48220bdba2 | 2023-01-09 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | Gland Pharma Limited | 2528999b-9f09-4e64-89fc-1e3d69c2d0b6 | 2022-11-23 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| Mitomycin | MITOMYCIN | Hikma Pharmaceuticals USA Inc. | fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8 | 2022-09-27 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | Meitheal Pharmaceuticals Inc. | 9dd0e3f2-0938-4c57-8d09-040b5405b44f | 2022-09-08 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
| MITOMYCIN | MITOMYCIN | Gland Pharma Limited | 650d3024-b9a9-4018-8115-0951acfe3145 | 2021-10-22 | Boxed warning, Warnings, Adverse reactions | MITOMYCIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.