Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076349
Company: CUSTOPHARM INC
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 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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