Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078393
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/2ML (25MG/ML) | INJECTABLE;INJECTION | Prescription | AP1 | 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/2ML (25MG/ML)
TE Code = AP1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 090724 | AREVA PHARMS |
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 078393 | FRESENIUS KABI USA |
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP1 | 076661 | SAGENT PHARMS INC |