Application 064180

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	5MG/VIAL	No	No
002	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	20MG/VIAL	No	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
A064180-001	MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP		1999-12-23
A064180-002	MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1999-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A064180-001	AP
A064180-002	AP

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 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064180-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064180-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1999-12-23	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A064180-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064180-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064180-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064180-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064180-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064180-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064180-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064180-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064180-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064180-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064180-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064180-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064180-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064180-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064180-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064180-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064180-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A064180-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064180-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A064180-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064180-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064180-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064180-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A064180-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064180-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A064180-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064180-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064180-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064180-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064180-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064180-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064180-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064180-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064180-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064180-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A064180-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064180-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A064180-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064180-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064180-002	AP	1	`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 brand name: Mitomycin generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Bryant Ranch Prepack	5f41676f-f687-47db-871c-35bbf2447a98	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin 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 brand name: Mitomycin generic name: MITOMYCIN
MUTAMYCIN	MITOMYCIN	Accord BioPharma Inc.	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Bryant Ranch Prepack	799a06b1-7697-42a3-b31a-c9d621b34f6f	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	BluePoint Laboratories	57129df7-d6b1-419e-90ec-54f9b5182e7c	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Eugia US LLC	f5a010cf-5954-4e6d-acfa-fb414efdf471	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Archis Pharma LLC	cef5026c-8bc3-4428-a178-6effff4dcb3f	2023-09-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Archis Pharma LLC	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2023-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Sagent Pharmaceuticals	10c41a58-c305-4240-80d2-caa070412648	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Sagent Pharmaceuticals	0171a1c8-c474-4ec1-a11d-6b93a21ca460	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Fresenius Kabi USA, LLC	bc937e3d-7167-49a5-b6b1-004b0f89d8c4	2023-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Fresenius Kabi USA, LLC	6a4fbc96-e35d-41c2-91fc-4b48220bdba2	2023-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Gland Pharma Limited	2528999b-9f09-4e64-89fc-1e3d69c2d0b6	2022-11-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN
Mitomycin	MITOMYCIN	Hikma Pharmaceuticals USA Inc.	fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8	2022-09-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mitomycin generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Meitheal Pharmaceuticals Inc.	9dd0e3f2-0938-4c57-8d09-040b5405b44f	2022-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN
MITOMYCIN	MITOMYCIN	Gland Pharma Limited	650d3024-b9a9-4018-8115-0951acfe3145	2021-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MITOMYCIN generic name: MITOMYCIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8355	ORIG	1999-12-23