Details for New Drug Application (NDA): 022150
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The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.
Summary for 022150
Tradename: | FIRAZYR |
Applicant: | Takeda Pharms Usa |
Ingredient: | icatibant acetate |
Patents: | 0 |
Pharmacology for NDA: 022150
Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Suppliers and Packaging for NDA: 022150
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-702 | 54092-702-01 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS |
FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-702 | 54092-702-02 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | ||||
Approval Date: | Aug 25, 2011 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 022150
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | FIRAZYR | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 022150-001 | Aug 25, 2011 | ⤷ Subscribe | ⤷ Subscribe |
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