Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040278
Company: FRESENIUS KABI USA
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 Yes
FLUOROURACIL FLUOROURACIL 5GM/100ML (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/98/40278_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
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.

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/98/40278_Fluorouracil_Prntlbl.pdf

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 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 202669 MYLAN LABS LTD
FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203609 SAGENT PHARMS INC
FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040334 TEVA PHARMS USA

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 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 202669 MYLAN LABS LTD
FLUOROURACIL FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203609 SAGENT PHARMS INC
FLUOROURACIL FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040334 TEVA PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English