Product NDC: | 42976-121 |
Proprietary Name: | ATryn |
Non Proprietary Name: | Antithrombin (Recombinant) |
Active Ingredient(s): | 1750 [iU]/1 & nbsp; Antithrombin (Recombinant) |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 42976-121 |
Labeler Name: | GTC Biotherapeutics, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125284 |
Marketing Category: | BLA |
Start Marketing Date: | 20090506 |
Package NDC: | 42976-121-02 |
Package Description: | 1 VIAL in 1 CARTON (42976-121-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
NDC Code | 42976-121-02 |
Proprietary Name | ATryn |
Package Description | 1 VIAL in 1 CARTON (42976-121-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Product NDC | 42976-121 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Antithrombin (Recombinant) |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20090506 |
Marketing Category Name | BLA |
Labeler Name | GTC Biotherapeutics, Inc. |
Substance Name | ANTITHROMBIN ALFA |
Strength Number | 1750 |
Strength Unit | [iU]/1 |
Pharmaceutical Classes | Recombinant Antithrombin [EPC],Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA] |