Application Information

This drug has been submitted to the FDA under the reference 012209/001.

Names and composition

"FLUOROURACIL" is the commercial name of a drug composed of FLUOROURACIL.
It belongs to the class Other antineoplastics and is used in Antineoplastics (Cancer)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
012209/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012209/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
040278/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
040278/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
040279/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
040279/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040291/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
040333/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040334/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
040334/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
040379/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
040743/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
040743/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040772/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040798/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
040798/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
076526/001 FLUOROURACIL FLUOROURACIL SOLUTION/TOPICAL 2%
076526/002 FLUOROURACIL FLUOROURACIL SOLUTION/TOPICAL 5%
077524/001 FLUOROURACIL FLUOROURACIL CREAM/TOPICAL 5%
087791/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
087792/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
088766/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
088767/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
088929/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089152/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089368/001 FLUOROURACIL FLUOROURACIL Injectable/ Injection 50MG per ML
089428/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089434/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089455/001 FLUOROURACIL FLUOROURACIL Injectable/ Injection 50MG per ML
089508/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089519/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
090368/001 FLUOROURACIL FLUOROURACIL CREAM/TOPICAL 5%
091299/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
091299/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
202668/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
202668/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
202669/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
202669/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
203122/001 FLUOROURACIL FLUOROURACIL CREAM/TOPICAL 0.5%
203608/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
203608/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
203609/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
203609/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
012209/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012209/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
016765/001 FLUOROPLEX FLUOROURACIL SOLUTION/TOPICAL 1%
016831/001 EFUDEX FLUOROURACIL SOLUTION/TOPICAL 2%
016831/002 EFUDEX FLUOROURACIL SOLUTION/TOPICAL 5%
016831/003 EFUDEX FLUOROURACIL CREAM/TOPICAL 5%
016988/001 FLUOROPLEX FLUOROURACIL CREAM/TOPICAL 1%
017959/001 ADRUCIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
020985/001 CARAC FLUOROURACIL CREAM/TOPICAL 0.5%
022259/001 TOLAK FLUOROURACIL CREAM/TOPICAL 4%
040023/001 ADRUCIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
040278/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
040278/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
040279/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
040279/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040291/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
040333/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040334/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
040334/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
040379/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
040743/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
040743/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040772/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
040798/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
040798/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
076526/001 FLUOROURACIL FLUOROURACIL SOLUTION/TOPICAL 2%
076526/002 FLUOROURACIL FLUOROURACIL SOLUTION/TOPICAL 5%
077524/001 FLUOROURACIL FLUOROURACIL CREAM/TOPICAL 5%
081222/001 ADRUCIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
081225/001 ADRUCIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
087791/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
087792/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
088766/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
088767/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
088929/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089152/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089368/001 FLUOROURACIL FLUOROURACIL Injectable/ Injection 50MG per ML
089428/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089434/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089455/001 FLUOROURACIL FLUOROURACIL Injectable/ Injection 50MG per ML
089508/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
089519/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 50MG per ML
090368/001 FLUOROURACIL FLUOROURACIL CREAM/TOPICAL 5%
091299/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
091299/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
202668/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
202668/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
202669/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
202669/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)
203122/001 FLUOROURACIL FLUOROURACIL CREAM/TOPICAL 0.5%
203608/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 500MG per 10ML (50MG per ML)
203608/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 1GM per 20ML (50MG per ML)
203609/001 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 2.5GM per 50ML (50MG per ML)
203609/002 FLUOROURACIL FLUOROURACIL INJECTABLE/INJECTION 5GM per 100ML (50MG per ML)

Manufacturers

Manufacturer name
Meda Pharmaceuticals Ltd

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