Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077790
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
FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 200648 MYLAN LABS LTD

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