Application 216510

Type: ANDA
Sponsor: XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NELARABINE	NELARABINE	INJECTABLE;INTRAVENOUS	250MG/50ML (5MG/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
A216510-001	NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2024-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216510-001	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.

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	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216510-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2024-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216510-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216510-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216510-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216510-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216510-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216510-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216510-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216510-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216510-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216510-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216510-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216510-001	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216510-001	AP	1	`a50c72e98297…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nelarabine	NELARABINE	Amneal Pharmaceuticals LLC	8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
Nelarabine	NELARABINE	Meitheal Pharmaceuticals Inc	21919314-5c25-49ab-beba-099983ed4a71	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
nelarabine	NELARABINE	Shorla Oncology Inc.	fc401b06-4e3b-413e-a854-3e031c433862	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: nelarabine generic name: NELARABINE
NELARABINE	NELARABINE	Alembic Pharmaceuticals Inc.	a2a08758-9a9d-49a2-a498-9da109045ee9	2025-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NELARABINE generic name: NELARABINE
Nelarabine	NELARABINE	Zydus Pharmaceuticals USA Inc.	8cb23281-93ca-40b8-b8e0-c57dd4298322	2025-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
Nelarabine	NELARABINE	Gland Pharma Limited	651bf4d2-75b0-4a60-8014-7006ffe61084	2025-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
Nelarabine	NELARABINE	Zydus Pharmaceuticals USA Inc.	e425731e-626b-4141-a997-fb85e077c2a4	2025-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
Arranon	NELARABINE	Sandoz Inc	0f9051de-5c4d-4c0f-8c19-e15214498cca	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NELARABINE
Nelarabine	NELARABINE	Dr. Reddy's Laboratories, Inc.	57275b05-f40f-7298-5a5e-93594bc41437	2025-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
NELARABINE	NELARABINE	Alembic Pharmaceuticals Limited	03ad6056-0e71-4e7c-842a-a5f87649bdcd	2024-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NELARABINE generic name: NELARABINE
Nelarabine	NELARABINE	Sagent Pharmaceuticals	f60da70f-2f9e-421d-a277-95b1edb57a71	2024-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nelarabine generic name: NELARABINE
NELARABINE	NELARABINE	Novadoz Pharmaceuticals LLC	d556a9e7-310b-41dc-99f8-a281fe7da3fe	2023-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NELARABINE generic name: NELARABINE
Nelarabine	NELARABINE	Zydus Lifesciences Limited	877b69a0-0899-455d-926e-f5a7478c31f8	2022-11-05		Name fallback brand name: Nelarabine generic name: NELARABINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.