Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040279
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) 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
09/30/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040279_fluorouracil_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2017 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

12/05/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

07/06/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Prntlbl.pdf

FLUOROURACIL

INJECTABLE;INJECTION; 1GM/20ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040743 ACCORD HLTHCARE
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040279 FRESENIUS KABI USA
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 210123 GLAND PHARMA LTD
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203608 SAGENT PHARMS INC

INJECTABLE;INJECTION; 500MG/10ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040743 ACCORD HLTHCARE
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040279 FRESENIUS KABI USA
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 210123 GLAND PHARMA LTD
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203608 SAGENT PHARMS INC
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040333 TEVA PHARMS USA

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