Product NDC: | 54092-701 |
Proprietary Name: | VPRIV |
Non Proprietary Name: | velaglucerase alfa |
Active Ingredient(s): | 2.5 mg/mL & nbsp; velaglucerase alfa |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54092-701 |
Labeler Name: | Shire US Manufacturing Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022575 |
Marketing Category: | NDA |
Start Marketing Date: | 20100226 |
Package NDC: | 54092-701-04 |
Package Description: | 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS |
NDC Code | 54092-701-04 |
Proprietary Name | VPRIV |
Package Description | 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS |
Product NDC | 54092-701 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | velaglucerase alfa |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20100226 |
Marketing Category Name | NDA |
Labeler Name | Shire US Manufacturing Inc. |
Substance Name | VELAGLUCERASE ALFA |
Strength Number | 2.5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] |