You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210118


✉ Email this page to a colleague

« Back to Dashboard


NDA 210118 describes ICATIBANT ACETATE, which is a drug marketed by Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Slayback Pharma Llc, and Teva Pharms Usa, and is included in nine NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.
Summary for 210118
Tradename:ICATIBANT ACETATE
Applicant:Teva Pharms Usa
Ingredient:icatibant acetate
Patents:0
Pharmacology for NDA: 210118
Suppliers and Packaging for NDA: 210118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 210118 ANDA Teva Pharmaceuticals USA, Inc. 0093-3066 0093-3066-34 1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE
ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 210118 ANDA Teva Pharmaceuticals USA, Inc. 0093-3066 0093-3066-93 3 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Jul 15, 2019TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.