Application 020229
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| 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| CLADRIBINE | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| 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| N020229-001 | LEUSTATIN | CLADRIBINE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-02-26 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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UTC | 2022-10 | N020229-001 | LEUSTATIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-02-26 | f41ea6bd6efb… | |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UTC | 2022-09 | N020229-001 | LEUSTATIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-02-26 | e64feba35796… | |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ZIP | 2022-07 | N020229-001 | LEUSTATIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-02-26 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020229-001 | LEUSTATIN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-02-26 | a50c72e98297… |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.
| 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 | CLADRIBINE |
| Cladribine | CLADRIBINE | Apotex Corp. | 407c52d5-6498-7da5-da35-acc9ca73ced3 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
| Mavenclad | CLADRIBINE | EMD Serono, Inc. | 9c75e30a-a410-40f1-b653-04d532bd9144 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
| Cladribine | CLADRIBINE | Hisun Pharmaceuticals USA, Inc. | 71c39b37-33b5-42e1-bf4f-93ff751cc7fe | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
| Cladribine | CLADRIBINE | Genvion Corporation | f1d650a5-4205-720b-f39b-4213277b6612 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
| Cladribine | CLADRIBINE | Hisun Pharmaceuticals USA, Inc. | f538cba9-001a-4a21-e053-2a95a90a00ec | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
| Cladribine | CLADRIBINE | Fresenius Kabi USA, LLC | a2592a9b-bca6-4a5a-89c2-855a0634d5fe | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
| Cladribine | CLADRIBINE | Hikma Pharmaceuticals USA Inc. | 5736aecc-cc1d-47dd-86c0-5fb2e9d70f61 | 2023-04-19 | Boxed warning, Warnings, Adverse reactions | CLADRIBINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.