| Product NDC: | 0049-0116 |
| Proprietary Name: | ERAXIS |
| Non Proprietary Name: | ANIDULAFUNGIN |
| Active Ingredient(s): | 100 mg/30mL & nbsp; ANIDULAFUNGIN |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0049-0116 |
| Labeler Name: | Roerig |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021632 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20060217 |
| Package NDC: | 0049-0116-28 |
| Package Description: | 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28) |
| NDC Code | 0049-0116-28 |
| Proprietary Name | ERAXIS |
| Package Description | 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28) |
| Product NDC | 0049-0116 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ANIDULAFUNGIN |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20060217 |
| Marketing Category Name | NDA |
| Labeler Name | Roerig |
| Substance Name | ANIDULAFUNGIN |
| Strength Number | 100 |
| Strength Unit | mg/30mL |
| Pharmaceutical Classes | Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] |