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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216494
Company: KINDOS

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/24/2024 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2026 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216494Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215699Orig1s005,216494Orig1s005ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/05/2026 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216494Orig1s005lbl.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 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
FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 216494 KINDOS
FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203609 SAGENT PHARMS INC
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