Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078544
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/15/2007 | ORIG-1 | Approval |
Label is not available on this site. |
FLUDARABINE PHOSPHATE
INJECTABLE;INJECTION; 50MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078610 | ACTAVIS TOTOWA |
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078544 | FRESENIUS KABI USA |
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076349 | HIKMA |