Product NDC: | 58468-1983 |
Proprietary Name: | Cerezyme |
Non Proprietary Name: | IMIGLUCERASE |
Active Ingredient(s): | 40 U/mL & nbsp; IMIGLUCERASE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-1983 |
Labeler Name: | Genzyme Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020367 |
Marketing Category: | NDA |
Start Marketing Date: | 19940523 |
Package NDC: | 58468-1983-1 |
Package Description: | 5 mL in 1 VIAL, GLASS (58468-1983-1) |
NDC Code | 58468-1983-1 |
Proprietary Name | Cerezyme |
Package Description | 5 mL in 1 VIAL, GLASS (58468-1983-1) |
Product NDC | 58468-1983 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | IMIGLUCERASE |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 19940523 |
Marketing Category Name | NDA |
Labeler Name | Genzyme Corporation |
Substance Name | IMIGLUCERASE |
Strength Number | 40 |
Strength Unit | U/mL |
Pharmaceutical Classes | Glucosylceramidase [Chemical/Ingredient],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] |