Product NDC: | 54092-702 |
Proprietary Name: | Firazyr |
Non Proprietary Name: | icatibant acetate |
Active Ingredient(s): | 30 mg/3mL & nbsp; icatibant acetate |
Administration Route(s): | SUBCUTANEOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54092-702 |
Labeler Name: | Shire US Manufacturing Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022150 |
Marketing Category: | NDA |
Start Marketing Date: | 20110825 |
Package NDC: | 54092-702-02 |
Package Description: | 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) > 3 mL in 1 SYRINGE, GLASS |
NDC Code | 54092-702-02 |
Proprietary Name | Firazyr |
Package Description | 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) > 3 mL in 1 SYRINGE, GLASS |
Product NDC | 54092-702 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | icatibant acetate |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | SUBCUTANEOUS |
Start Marketing Date | 20110825 |
Marketing Category Name | NDA |
Labeler Name | Shire US Manufacturing Inc. |
Substance Name | ICATIBANT ACETATE |
Strength Number | 30 |
Strength Unit | mg/3mL |
Pharmaceutical Classes | Bradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA] |