Application 021877
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARRANON | NELARABINE | INJECTABLE;INTRAVENOUS | 250MG/50ML (5MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0683 | Arranon | nelarabine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0683 | Arranon | nelarabine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0683 | Arranon | nelarabine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0683 | Arranon | nelarabine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0683 | Arranon | nelarabine | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81547 | SUPPL | 2025-03-13 |
| 81546 | SUPPL | 2025-03-13 |
| 72911 | SUPPL | 2022-12-16 |
| 72910 | SUPPL | 2022-12-15 |
| 59546 | SUPPL | 2019-08-02 |
| 59539 | SUPPL | 2019-08-01 |
| 56819 | SUPPL | 2018-12-20 |
| 56607 | SUPPL | 2018-11-30 |
| 54778 | SUPPL | 2018-07-06 |
| 28758 | SUPPL | 2012-02-07 |
| 16505 | SUPPL | 2012-02-06 |
| 28757 | SUPPL | 2009-12-24 |
| 6361 | SUPPL | 2009-12-24 |
| 37804 | SUPPL | 2009-12-16 |
| 16504 | SUPPL | 2009-12-16 |
| 42335 | ORIG | 2006-01-06 |
| 37803 | ORIG | 2005-11-01 |
| 6360 | ORIG | 2005-11-01 |