Application 078393
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
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 | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-192 | Fludarabine | FLUDARABINE PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-192 | Fludarabine | FLUDARABINE PHOSPHATE | Fresenius Kabi USA, LLC | ANDA | Current |