Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076661
Company: SAGENT PHARMS INC
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 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
04/28/2004 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
06/14/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION; 50MG/2ML (25MG/ML)
TE Code = AP

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 AP 203738 ACTAVIS LLC
FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE;INJECTION Prescription No AP 090724 AREVA PHARMS
FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE;INJECTION Prescription No AP 078393 FRESENIUS KABI USA
FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE;INJECTION Prescription No AP 076661 SAGENT PHARMS INC
FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022137 SANDOZ

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