Product NDC: | 57902-249 |
Proprietary Name: | ERWINAZE |
Non Proprietary Name: | Asparaginase |
Active Ingredient(s): | 10000 [iU]/mL & nbsp; Asparaginase |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 57902-249 |
Labeler Name: | Jazz Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125359 |
Marketing Category: | BLA |
Start Marketing Date: | 20111118 |
Package NDC: | 57902-249-05 |
Package Description: | 5 VIAL, GLASS in 1 CARTON (57902-249-05) > 1 mL in 1 VIAL, GLASS (57902-249-01) |
NDC Code | 57902-249-05 |
Proprietary Name | ERWINAZE |
Package Description | 5 VIAL, GLASS in 1 CARTON (57902-249-05) > 1 mL in 1 VIAL, GLASS (57902-249-01) |
Product NDC | 57902-249 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Asparaginase |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20111118 |
Marketing Category Name | BLA |
Labeler Name | Jazz Pharmaceuticals, Inc. |
Substance Name | ASPARAGINASE |
Strength Number | 10000 |
Strength Unit | [iU]/mL |
Pharmaceutical Classes | Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] |