Product NDC: | 0469-3051 |
Proprietary Name: | AmBisome |
Non Proprietary Name: | amphotericin B |
Active Ingredient(s): | 50 mg/12.5mL & nbsp; amphotericin B |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0469-3051 |
Labeler Name: | Astellas Pharma US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA050740 |
Marketing Category: | NDA |
Start Marketing Date: | 19970811 |
Package NDC: | 0469-3051-30 |
Package Description: | 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30) |
NDC Code | 0469-3051-30 |
Proprietary Name | AmBisome |
Package Description | 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30) |
Product NDC | 0469-3051 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | amphotericin B |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 19970811 |
Marketing Category Name | NDA |
Labeler Name | Astellas Pharma US, Inc. |
Substance Name | AMPHOTERICIN B |
Strength Number | 50 |
Strength Unit | mg/12.5mL |
Pharmaceutical Classes | Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] |