| Product NDC: | 55390-308 |
| Proprietary Name: | amifostine |
| Non Proprietary Name: | amifostine |
| Active Ingredient(s): | 500 mg/10mL & nbsp; amifostine |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55390-308 |
| Labeler Name: | Bedford Laboratories |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020221 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080402 |
| Package NDC: | 55390-308-03 |
| Package Description: | 3 VIAL, SINGLE-USE in 1 CARTON (55390-308-03) > 10 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 55390-308-03 |
| Proprietary Name | amifostine |
| Package Description | 3 VIAL, SINGLE-USE in 1 CARTON (55390-308-03) > 10 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 55390-308 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | amifostine |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20080402 |
| Marketing Category Name | NDA |
| Labeler Name | Bedford Laboratories |
| Substance Name | AMIFOSTINE |
| Strength Number | 500 |
| Strength Unit | mg/10mL |
| Pharmaceutical Classes | Cytoprotective Agent [EPC],Free Radical Scavenging Activity [MoA] |