An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040279
Company: FRESENIUS KABI USA

Products on ANDA 040279

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	No
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040279

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
03/21/2024	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/040279s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/040278Orig1s027;040279Orig1s030ltr.pdf
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.

Labels for ANDA 040279

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/040279s030lbl.pdf
09/30/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040279

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	202668	EUGIA PHARMA SPECLTS
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	202668	EUGIA PHARMA SPECLTS
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

Top