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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212081

ICATIBANT ACETATE (ICATIBANT ACETATE)
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: ICATIBANT ACETATE
Proprietary Name: ICATIBANT ACETATE
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212081
Product Number: 001
Approval Date: Dec 16, 2020
Applicant Holder Full Name: NANG KUANG PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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