Orange Book product · Brand (NDA)

QUZYTTIR

CETIRIZINE HYDROCHLORIDE

Brand (NDA)NDA 211415RX ESTEVE

Oct 04, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 04, 2019
6 yr 10 mo ago
Today
Patent 8513259 expires
Listed method-of-use patent (U-2636) expiration.
Feb 11, 2030
in 3 yr 8 mo
Patent 9119771 expires
Listed method-of-use patent (U-2635) expiration.
Feb 11, 2030
in 3 yr 8 mo
Patent 9180090 expires
Listed method-of-use patent (U-2635) expiration.
Feb 11, 2030
in 3 yr 8 mo
Patent 8263581 expires
Listed method-of-use patent (U-2635) expiration.
Feb 28, 2030
in 3 yr 9 mo
Patent 8314083 expires
Listed method-of-use patent (U-2634) expiration.
Feb 28, 2030
in 3 yr 9 mo

Active ingredient

CETIRIZINE HYDROCHLORIDE

Strength

10MG/ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 211415

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8513259	Feb 11, 2030	in 3 yr 8 mo	U-2636
9119771	Feb 11, 2030	in 3 yr 8 mo	U-2635
9180090	Feb 11, 2030	in 3 yr 8 mo	U-2635
8263581	Feb 28, 2030	in 3 yr 9 mo	U-2635
8314083	Feb 28, 2030	in 3 yr 9 mo	U-2634