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Application 022137
- Type
- NDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 66758-046 | Fludarabine Phosphate | Fludarabine Phosphate | Sandoz Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81442 | SUPPL | 2025-03-05 |
| 80254 | SUPPL | 2024-11-21 |
| 80247 | SUPPL | 2024-11-20 |
| 29307 | SUPPL | 2011-03-02 |
| 17002 | SUPPL | 2011-02-24 |
| 42426 | ORIG | 2008-11-17 |
| 38296 | ORIG | 2007-09-26 |
| 29306 | ORIG | 2007-09-25 |