Composition
- Active ingredients
- MITOMYCIN 5MG/VIAL
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- MITOMYCIN 20MG/VIAL · InjectableANDA062336-002 · Discontinued
- MITOMYCIN 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableANDA062336-003 · Discontinued
- MITOMYCIN 5MG/VIAL · InjectableThis page
- MITOMYCIN 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA050450-001 · Discontinued
- MITOMYCIN 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA050450-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA062336.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Mutamycin
- Active substance
- mitomycin
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Bristol Myers
- Status
- Discontinued
- FDA approval
- 24 Aug 1981
- Application
- ANDA062336-001