Application 203386

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203386-001	MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP		2017-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203386-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203386-001	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	2017-10-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203386-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203386-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203386-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203386-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203386-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203386-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203386-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203386-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203386-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203386-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203386-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203386-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203386-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203386-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203386-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203386-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203386-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203386-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203386-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203386-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203386-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203386-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203386-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203386-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203386-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203386-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203386-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203386-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203386-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203386-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203386-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203386-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203386-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203386-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203386-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203386-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203386-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203386-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203386-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203386-001	AP	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mitomycin	MITOMYCIN	Archis Pharma LLC	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2023-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203386 application number: ANDA203386

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-520	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-997	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-997	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current