Application 076349
- Type
- ANDA
- Sponsor
- CUSTOPHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24201-237 | fludarabine phosphate | fludarabine phosphate | Leucadia Pharmaceuticals | ANDA | Current |
| 24201-237 | fludarabine phosphate | fludarabine phosphate | Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | ANDA | Current |
| 25021-237 | fludarabine phosphate | fludarabine phosphate | Sagent Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22555 | ORIG | 2007-04-02 |