Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040334
Company: TEVA PHARMS USA

Products on ANDA 040334

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040334_fluorouracil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/040334s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/040334Orig1s033;040333Orig1s033ltr.pdf
12/28/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 040334

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/040334s033lbl.pdf
02/25/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Prntlbl.pdf