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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212081


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NDA 212081 describes ICATIBANT ACETATE, which is a drug marketed by Alembic, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ICATIBANT ACETATE profile page.

The generic ingredient in ICATIBANT ACETATE 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 212081
Tradename:ICATIBANT ACETATE
Applicant:Nang Kuang Pharm Co
Ingredient:icatibant acetate
Patents:0
Pharmacology for NDA: 212081
Suppliers and Packaging for NDA: 212081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 212081 ANDA Apotex Corp. 60505-6214 60505-6214-1 1 SYRINGE, GLASS in 1 CARTON (60505-6214-1) / 3 mL in 1 SYRINGE, GLASS
ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 212081 ANDA Bryant Ranch Prepack 72162-2106 72162-2106-2 1 SYRINGE, GLASS in 1 CARTON (72162-2106-2) / 3 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Dec 16, 2020TE:APRLD:No

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