Orange Book product · Brand (NDA)

CHILDREN'S ALLEGRA ALLERGY

FEXOFENADINE HYDROCHLORIDE

Brand (NDA)NDA 201373OTC CHATTEM SANOFI

Jan 24, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 24, 2011
15 yr 8 mo ago
Today
Patent 8933097 expires
Listed drug product patent expiration.
Aug 02, 2030
in 4 yr 2 mo

Active ingredient

FEXOFENADINE HYDROCHLORIDE

Strength

30MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 201373

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
8933097	Aug 02, 2030	in 4 yr 2 mo	Product