Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040798
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
FLUOROURACIL FLUOROURACIL 2.5GM/50ML (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
04/26/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/27/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

FLUOROURACIL

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

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

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