Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076349
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
08/28/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076349.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/08/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
03/21/2011 | SUPPL-4 | Labeling-Package Insert |
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 |