Product NDC: | 68135-020 |
Proprietary Name: | NAGLAZYME |
Non Proprietary Name: | galsulfase |
Active Ingredient(s): | 5 mg/5mL & nbsp; galsulfase |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68135-020 |
Labeler Name: | BioMarin Pharmaceutical Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125117 |
Marketing Category: | BLA |
Start Marketing Date: | 20050609 |
Package NDC: | 68135-020-01 |
Package Description: | 1 VIAL in 1 CARTON (68135-020-01) > 5 mL in 1 VIAL |
NDC Code | 68135-020-01 |
Proprietary Name | NAGLAZYME |
Package Description | 1 VIAL in 1 CARTON (68135-020-01) > 5 mL in 1 VIAL |
Product NDC | 68135-020 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | galsulfase |
Dosage Form Name | SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20050609 |
Marketing Category Name | BLA |
Labeler Name | BioMarin Pharmaceutical Inc. |
Substance Name | GALSULFASE |
Strength Number | 5 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] |