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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040278
Company: FRESENIUS KABI USA

Products on ANDA 040278

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040278

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/98/40278_Fluorouracil_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40278_Fluorouracil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040278_fluorouracil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/040278s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/040278Orig1s027;040279Orig1s030ltr.pdf
01/06/2017	SUPPL-16	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 040278

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/040278s027lbl.pdf
09/30/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40278_Fluorouracil_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040278

FLUOROURACIL

INJECTABLE;INJECTION; 2.5GM/50ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040798	ACCORD HLTHCARE
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	217295	ALEMBIC
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202669	EUGIA PHARMA SPECLTS
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040278	FRESENIUS KABI USA
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210124	GLAND PHARMA LTD
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203609	SAGENT PHARMS INC

INJECTABLE;INJECTION; 5GM/100ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040798	ACCORD HLTHCARE
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	217676	ALEMBIC
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202669	EUGIA PHARMA SPECLTS
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040278	FRESENIUS KABI USA
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210124	GLAND PHARMA LTD
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203609	SAGENT PHARMS INC

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