Details for New Drug Application (NDA): 022150

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NDA 022150 describes FIRAZYR, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the FIRAZYR profile page.

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

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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