Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson
Colorcon
Dow

Last Updated: June 28, 2022

Details for New Drug Application (NDA): 211415


✉ Email this page to a colleague

« Back to Dashboard

NDA 211415 describes QUZYTTIR, which is a drug marketed by JDP and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the QUZYTTIR profile page.

The generic ingredient in QUZYTTIR is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 211415
Tradename:QUZYTTIR
Applicant:Jdp
Ingredient:cetirizine hydrochloride
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 211415
Medical Subject Heading (MeSH) Categories for 211415
Suppliers and Packaging for NDA: 211415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUZYTTIR cetirizine hydrochloride SOLUTION;INTRAVENOUS 211415 NDA TerSera Therapeutics LLC 70720-100 70720-100-10 1 VIAL, GLASS in 1 CARTON (70720-100-10) > 1 mL in 1 VIAL, GLASS (70720-100-01)
QUZYTTIR cetirizine hydrochloride SOLUTION;INTRAVENOUS 211415 NDA TerSera Therapeutics LLC 70720-100 70720-100-25 25 VIAL, GLASS in 1 CARTON (70720-100-25) > 1 mL in 1 VIAL, GLASS (70720-100-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/ML (10MG/ML)
Approval Date:Oct 4, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 4, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:See Plans and PricingPatent Expiration:Feb 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE URTICARIA
Patent:See Plans and PricingPatent Expiration:Feb 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT IN PATIENTS WITH CONCOMITANT ANGIOEDEMA

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Dow
Moodys
Harvard Business School
Johnson and Johnson

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.