Application 050450

Type: NDA
Sponsor: BRISTOL

Application Products#

Product, Drug, Ingredient table
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MUTAMYCIN	MITOMYCIN	INJECTABLE;INJECTION	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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MUTAMYCIN	MITOMYCIN	INJECTABLE;INJECTION	20MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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-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N050450-001	MUTAMYCIN	MITOMYCIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N050450-002	MUTAMYCIN	MITOMYCIN	20MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
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UTC	2019-12	N050450-001	MUTAMYCIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`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UTC	2019-12	N050450-002	MUTAMYCIN	20MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050450-001	MUTAMYCIN	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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
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	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Bryant Ranch Prepack	5f41676f-f687-47db-871c-35bbf2447a98	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
JELMYTO	MITOMYCIN	UroGen Pharma, Inc.	3d3d5053-5427-4a68-a40b-edb60699521e	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
ZUSDURI	MITOMYCIN	UroGen Pharma, Inc	8dc68793-bca8-4e3d-b672-622961b58255	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitosol	MITOMYCIN	Mobius Therapeutics LLC	244002c6-c61d-43fe-9326-072797113979	2025-04-23	Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Accord Healthcare, Inc.	ff676355-313d-4575-8f2f-e4a1e9527477	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MUTAMYCIN	MITOMYCIN	Accord BioPharma Inc.	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MUTAMYCIN generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Bryant Ranch Prepack	799a06b1-7697-42a3-b31a-c9d621b34f6f	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	BluePoint Laboratories	57129df7-d6b1-419e-90ec-54f9b5182e7c	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Eugia US LLC	f5a010cf-5954-4e6d-acfa-fb414efdf471	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Archis Pharma LLC	cef5026c-8bc3-4428-a178-6effff4dcb3f	2023-09-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Archis Pharma LLC	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2023-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Sagent Pharmaceuticals	10c41a58-c305-4240-80d2-caa070412648	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Sagent Pharmaceuticals	0171a1c8-c474-4ec1-a11d-6b93a21ca460	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Fresenius Kabi USA, LLC	bc937e3d-7167-49a5-b6b1-004b0f89d8c4	2023-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Fresenius Kabi USA, LLC	6a4fbc96-e35d-41c2-91fc-4b48220bdba2	2023-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Gland Pharma Limited	2528999b-9f09-4e64-89fc-1e3d69c2d0b6	2022-11-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Hikma Pharmaceuticals USA Inc.	fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8	2022-09-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Meitheal Pharmaceuticals Inc.	9dd0e3f2-0938-4c57-8d09-040b5405b44f	2022-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Gland Pharma Limited	650d3024-b9a9-4018-8115-0951acfe3145	2021-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN

Reported adverse events (FAERS/openFDA)#

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