Application 205106

Type: ANDA
Sponsor: ATHENEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUSULFAN	BUSULFAN	INJECTABLE;INJECTION	6MG/ML	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
A205106-001	BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE / INJECTION			2018-09-21

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	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2018-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205106-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2018-09-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205106-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205106-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205106-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205106-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205106-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205106-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205106-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205106-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205106-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205106-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205106-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205106-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205106-001	AP	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A205106-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205106-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205106-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205106-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205106-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYLERAN	BUSULFAN	Waylis Therapeutics LLC	2da33e5b-dcfb-4cdf-b163-50398e42f41c	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUSULFAN
Busulfan	BUSULFAN	Eugia US LLC	06883ac0-4b2a-4f26-89bf-512d37b9ba7f	2024-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN
Busulfan	BUSULFAN	Accord Healthcare, Inc	fe0ddd44-ef02-4827-b164-7fcbb45bcc1b	2024-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN
Busulfan	BUSULFAN	Pharmascience Inc.	d0fe44f9-7747-4909-b927-3b24aa6e7e09	2022-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN
BUSULFAN	BUSULFAN	Hospira, Inc.	b9c7f0dc-988d-466e-8031-400ec4f60f21	2021-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUSULFAN generic name: BUSULFAN
Busulfan	BUSULFAN	Meitheal Pharmaceuticals Inc.	dc384f16-4e25-458e-874c-553f81c6d8c9	2021-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN
Busulfan	BUSULFAN	Meitheal Pharmaceuticals Inc.	6e68ab21-19bd-4b7e-b8d0-bf284d5af183	2021-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN
Busulfan	BUSULFAN	Amneal Pharmaceuticals LLC	ac9448da-37ad-4609-9aef-eedf8be0f69c	2020-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN
Busulfan	BUSULFAN	Sagent Pharmaceuticals	086a715e-4958-4bb5-9ebd-86171e6b6203	2020-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Busulfan generic name: BUSULFAN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70860-216	Busulfan	busulfan	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-216	Busulfan	busulfan	Athenex Pharmaceutical Division, LLC.	ANDA	Current