Product NDC: | 57665-101 |
Proprietary Name: | ABELCET |
Non Proprietary Name: | amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- |
Active Ingredient(s): | 5; 3.4; 1.5 mg/mL; mg/mL; mg/mL & nbsp; amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 57665-101 |
Labeler Name: | Sigma-Tau Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA050724 |
Marketing Category: | NDA |
Start Marketing Date: | 20101018 |
Package NDC: | 57665-101-41 |
Package Description: | 1 VIAL in 1 CARTON (57665-101-41) > 20 mL in 1 VIAL |
NDC Code | 57665-101-41 |
Proprietary Name | ABELCET |
Package Description | 1 VIAL in 1 CARTON (57665-101-41) > 20 mL in 1 VIAL |
Product NDC | 57665-101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20101018 |
Marketing Category Name | NDA |
Labeler Name | Sigma-Tau Pharmaceuticals, Inc. |
Substance Name | AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- |
Strength Number | 5; 3.4; 1.5 |
Strength Unit | mg/mL; mg/mL; mg/mL |
Pharmaceutical Classes | Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] |