FDA
Fluorouracil
The FDA lists this product in 58 strengths and forms.
Composition
- Active ingredients
- FLUOROURACIL 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FLUOROURACIL 5% · CreamANDA077524-001 · Prescription
- FLUOROURACIL 50MG/ML · InjectableANDA089428-001 · Discontinued
- FLUOROURACIL 50MG/ML · InjectableANDA089519-001 · Discontinued
- FLUOROURACIL 5% · CreamANDA090368-001 · Prescription
- FLUOROURACIL 5GM/100ML (50MG/ML) · InjectableANDA210124-002 · Prescription
- FLUOROURACIL 2.5GM/50ML (50MG/ML) · InjectableANDA210124-001 · Prescription
- FLUOROURACIL 5GM/100ML (50MG/ML) · InjectableANDA215699-001 · Prescription
- FLUOROURACIL 50MG/ML · InjectableANDA040291-001 · Discontinued
- FLUOROURACIL 50MG/ML · InjectableANDA089508-001 · Discontinued
- FLUOROURACIL 5% · CreamANDA216942-001 · Prescription
- FLUOROURACIL 2.5GM/50ML (50MG/ML) · InjectableANDA217295-001 · Prescription
- FLUOROURACIL 50MG/ML · InjectableANDA088929-001 · Discontinued
At a glance
- Brand name
- Fluorouracil
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Spectrum Pharms
- Status
- Discontinued
- FDA approval
- 25 Apr 1962
- Application
- NDA012209-001