Product NDC: | 0781-3314 |
Proprietary Name: | Argatroban |
Non Proprietary Name: | Argatroban |
Active Ingredient(s): | 1 mg/mL & nbsp; Argatroban |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0781-3314 |
Labeler Name: | Sandoz Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022434 |
Marketing Category: | NDA |
Start Marketing Date: | 20110906 |
Package NDC: | 0781-3314-95 |
Package Description: | 10 CARTON in 1 CARTON (0781-3314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-3314-91) > 50 mL in 1 VIAL, SINGLE-USE |
NDC Code | 0781-3314-95 |
Proprietary Name | Argatroban |
Package Description | 10 CARTON in 1 CARTON (0781-3314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-3314-91) > 50 mL in 1 VIAL, SINGLE-USE |
Product NDC | 0781-3314 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Argatroban |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20110906 |
Marketing Category Name | NDA |
Labeler Name | Sandoz Inc |
Substance Name | ARGATROBAN |
Strength Number | 1 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] |