Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022150

FIRAZYR (ICATIBANT ACETATE)
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Marketing Status: Prescription

Active Ingredient: ICATIBANT ACETATE
Proprietary Name: FIRAZYR
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022150
Product Number: 001
Approval Date: Aug 25, 2011
Applicant Holder Full Name: SHIRE ORPHAN THERAPIES INC
Marketing Status:  Prescription
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