Application 020229

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEUSTATIN	CLADRIBINE	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N020229-001	LEUSTATIN	CLADRIBINE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1993-02-26

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020229-001	LEUSTATIN	1MG/ML	INJECTABLE / INJECTION	RLD	1993-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020229-001	LEUSTATIN	1MG/ML	INJECTABLE / INJECTION	RLD	1993-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020229-001	LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-02-26	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cladribine	CLADRIBINE	Sandoz Inc.	e0b363cb-db83-44d6-89d0-1f7176be7459	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Cladribine	CLADRIBINE	Apotex Corp.	407c52d5-6498-7da5-da35-acc9ca73ced3	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Mavenclad	CLADRIBINE	EMD Serono, Inc.	9c75e30a-a410-40f1-b653-04d532bd9144	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Cladribine	CLADRIBINE	Hisun Pharmaceuticals USA, Inc.	71c39b37-33b5-42e1-bf4f-93ff751cc7fe	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Cladribine	CLADRIBINE	Genvion Corporation	f1d650a5-4205-720b-f39b-4213277b6612	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Cladribine	CLADRIBINE	Hisun Pharmaceuticals USA, Inc.	f538cba9-001a-4a21-e053-2a95a90a00ec	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Cladribine	CLADRIBINE	Fresenius Kabi USA, LLC	a2592a9b-bca6-4a5a-89c2-855a0634d5fe	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE
Cladribine	CLADRIBINE	Hikma Pharmaceuticals USA Inc.	5736aecc-cc1d-47dd-86c0-5fb2e9d70f61	2023-04-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLADRIBINE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48231	SUPPL	2012-08-03
48230	SUPPL	2012-08-03
48232	SUPPL	2006-07-03
48235	SUPPL	2002-08-22
48234	SUPPL	2002-08-20
48233	SUPPL	2002-08-20