Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075837
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOXURIDINE FLOXURIDINE 500MG/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
02/22/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75837ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075837.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

11/26/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/2002 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/26/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

FLOXURIDINE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLOXURIDINE FLOXURIDINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 075837 FRESENIUS KABI USA
FLOXURIDINE FLOXURIDINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 075387 WEST-WARD PHARMS INT

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