Application 215102

Type: ANDA
Sponsor: EUGIA PHARMA

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 43.

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
A215102-001	BUSULFAN	BUSULFAN	6MG/ML	INJECTABLE / INJECTION			2024-06-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2024-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2024-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2024-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2024-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2024-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	2024-06-25	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215102-001	BUSULFAN	6MG/ML	INJECTABLE / INJECTION		2024-06-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215102-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215102-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215102-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215102-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215102-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215102-001	AP	1	`301d65b070ca…`

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
Busulfan	BUSULFAN	Eugia US LLC	06883ac0-4b2a-4f26-89bf-512d37b9ba7f	2024-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215102 application number: ANDA215102