Product NDC: | 57665-001 |
Proprietary Name: | Adagen |
Non Proprietary Name: | pegademase bovine |
Active Ingredient(s): | 250 [iU]/mL & nbsp; pegademase bovine |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 57665-001 |
Labeler Name: | Sigma-Tau Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA019818 |
Marketing Category: | NDA |
Start Marketing Date: | 20101018 |
Package NDC: | 57665-001-01 |
Package Description: | 4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE |
NDC Code | 57665-001-01 |
Proprietary Name | Adagen |
Package Description | 4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE |
Product NDC | 57665-001 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | pegademase bovine |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20101018 |
Marketing Category Name | NDA |
Labeler Name | Sigma-Tau Pharmaceuticals, Inc. |
Substance Name | PEGADEMASE BOVINE |
Strength Number | 250 |
Strength Unit | [iU]/mL |
Pharmaceutical Classes | Adenosine Deaminase [Chemical/Ingredient],Bovine Intestinal Adenosine Deaminase [EPC] |