Orange Book product · Brand (NDA)

XYZAL ALLERGY 24HR

LEVOCETIRIZINE DIHYDROCHLORIDE

Brand (NDA)NDA 209090OTC CHATTEM SANOFI

Jan 31, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 31, 2017
9 yr 6 mo ago
Today
Patent 8633194 expires
Listed drug product patent expiration.
Oct 16, 2027
in 1 yr 4 mo

Active ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Strength

2.5MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 209090

Product number

001

Marketing status

OTC

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
8633194	Oct 16, 2027	in 1 yr 4 mo	Product