Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022137
Company: SANDOZ
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 Yes 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
09/21/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022137lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022137s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022137_fludarabine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/12/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/29/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/10/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/25/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/25/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/25/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/18/2011 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022137s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/18/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf
09/21/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022137lbl.pdf

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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