Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077790
Company: HOSPIRA
Company: HOSPIRA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/06/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/28/2008 | SUPPL-1 | Labeling |
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 | 076349 | CUSTOPHARM INC |
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 | 077790 | HOSPIRA |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English