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Last Updated: May 11, 2021

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Details for New Drug Application (NDA): 211415

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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-three 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:
Patent:  Get Started for $10Patent Expiration:Feb 28, 2030Product Flag?Substance Flag?Delist Request?
Patent:  Get Started for $10Patent Expiration:Feb 28, 2030Product Flag?Substance Flag?Delist Request?

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