Application 064144

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	5MG/VIAL	No	Yes
002	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	20MG/VIAL	No	Yes
003	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	40MG/VIAL	No	Yes

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	RLD / RS	Approval date
A064144-001	MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30
A064144-002	MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30
A064144-003	MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A064144-001	AP
A064144-002	AP
A064144-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION			1998-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION			1998-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 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	A064144-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064144-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064144-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064144-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-003	AP	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mitomycin	MITOMYCIN	Accord Healthcare, Inc.	ff676355-313d-4575-8f2f-e4a1e9527477	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064144 application number: ANDA064144 ndc (product): 16729-115 ndc (product): 16729-116 ndc (product): 16729-108
MUTAMYCIN	MITOMYCIN	Accord BioPharma Inc.	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064144 application number: ANDA064144 ndc (product): 69448-001 ndc (product): 69448-003 ndc (product): 69448-002
Mitomycin	MITOMYCIN	BluePoint Laboratories	aad9a9a0-7204-452a-8b9b-6d625c4ee021	2021-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064144 application number: ANDA064144 ndc (product): 68001-389 ndc (product): 68001-391 ndc (product): 68001-390

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-108	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-108	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-108	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-115	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-115	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-115	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-116	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-116	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-116	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-246	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-246	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-246	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-247	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-247	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-247	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-248	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-248	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
16729-248	Mitomycin	Mitomycin	Accord Healthcare Inc	ANDA	Current
68001-389	Mitomycin	Mitomycin	BluePoint Laboratories	ANDA	Current
68001-389	Mitomycin	Mitomycin	BluePoint Laboratories	ANDA	Current
68001-390	Mitomycin	Mitomycin	BluePoint Laboratories	ANDA	Current
68001-390	Mitomycin	Mitomycin	BluePoint Laboratories	ANDA	Current
68001-391	Mitomycin	Mitomycin	BluePoint Laboratories	ANDA	Current
68001-391	Mitomycin	Mitomycin	BluePoint Laboratories	ANDA	Current
69448-001	MUTAMYCIN	Mitomycin	Accord BioPharma Inc.	ANDA	Current
69448-002	MUTAMYCIN	Mitomycin	Accord BioPharma Inc.	ANDA	Current
69448-003	MUTAMYCIN	Mitomycin	Accord BioPharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30618	ORIG	1998-04-30