Product NDC: | 0069-0106 |
Proprietary Name: | ELELYSO |
Non Proprietary Name: | Taliglucerase alfa |
Active Ingredient(s): | 200 U/5mL & nbsp; Taliglucerase alfa |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0069-0106 |
Labeler Name: | Pfizer Laboratories Div Pfizer Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022458 |
Marketing Category: | NDA |
Start Marketing Date: | 20120501 |
Package NDC: | 0069-0106-01 |
Package Description: | 1 VIAL, GLASS in 1 BOX (0069-0106-01) > 5 mL in 1 VIAL, GLASS |
NDC Code | 0069-0106-01 |
Proprietary Name | ELELYSO |
Package Description | 1 VIAL, GLASS in 1 BOX (0069-0106-01) > 5 mL in 1 VIAL, GLASS |
Product NDC | 0069-0106 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Taliglucerase alfa |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20120501 |
Marketing Category Name | NDA |
Labeler Name | Pfizer Laboratories Div Pfizer Inc |
Substance Name | TALIGLUCERASE ALFA |
Strength Number | 200 |
Strength Unit | U/5mL |
Pharmaceutical Classes | Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC],Glucosylceramidase [Chemical/Ingredient] |