Product NDC: | 58468-0070 |
Proprietary Name: | ALDURAZYME |
Non Proprietary Name: | laronidase |
Active Ingredient(s): | 2.9 mg/5mL & nbsp; laronidase |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-0070 |
Labeler Name: | Genzyme Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125058 |
Marketing Category: | BLA |
Start Marketing Date: | 20030430 |
Package NDC: | 58468-0070-1 |
Package Description: | 5 mL in 1 VIAL, GLASS (58468-0070-1) |
NDC Code | 58468-0070-1 |
Proprietary Name | ALDURAZYME |
Package Description | 5 mL in 1 VIAL, GLASS (58468-0070-1) |
Product NDC | 58468-0070 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | laronidase |
Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
Route Name | INTRAVENOUS |
Start Marketing Date | 20030430 |
Marketing Category Name | BLA |
Labeler Name | Genzyme Corporation |
Substance Name | LARONIDASE |
Strength Number | 2.9 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] |