Application 064117

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
003	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	40MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A064117-001	MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19
A064117-002	MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19
A064117-003	MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064117-002	AP
A064117-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064117-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	1995-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064117-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	1999-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064117-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION		1995-04-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A064117-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064117-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064117-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064117-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064117-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064117-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064117-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064117-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064117-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064117-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064117-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064117-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064117-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064117-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064117-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064117-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064117-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064117-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064117-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064117-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064117-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064117-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064117-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064117-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064117-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064117-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064117-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064117-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064117-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064117-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064117-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064117-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064117-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064117-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064117-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064117-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064117-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064117-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064117-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064117-003	AP	1	`bb7c543d1eb4…`

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 1 · 2 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	Exact identifier application applno (ANDA): 064117 application number: ANDA064117 ndc (product): 0143-9279 ndc (product): 0143-9280
Mitomycin	MITOMYCIN	Hikma Pharmaceuticals USA Inc.	fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8	2022-09-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064117 application number: ANDA064117 ndc (product): 0143-9135 ndc (product): 0143-9136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9135	Mitomycin	Mitomycin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9136	Mitomycin	Mitomycin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9279	Mitomycin	Mitomycin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9280	Mitomycin	Mitomycin	West-Ward Pharmaceuticals Corp	ANDA	Current