Skip to contentApplication 090724
- Type
- ANDA
- Sponsor
- AREVA PHARMS
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) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59923-604 | Fludarabine Phosphate | Fludarabine Phosphate | Areva Pharmaceuticals | ANDA | Current |
| 59923-604 | Fludarabine Phosphate | Fludarabine Phosphate | Areva Pharmaceuticals | ANDA | Current |
| 59923-604 | Fludarabine Phosphate | Fludarabine Phosphate | Areva Pharmaceuticals | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79641 | SUPPL | 2024-09-17 |