Orange Book product · Brand (NDA)

OMNARIS

CICLESONIDE

Brand (NDA)NDA 022004RX AZURITY

Oct 20, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 20, 2006
19 yr 11 mo ago
Today
Patent 8371292 expires
Listed method-of-use patent (U-1356) expiration.
Feb 01, 2028
in 1 yr 8 mo

Active ingredient

CICLESONIDE

Strength

0.05MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 022004

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
8371292	Feb 01, 2028	in 1 yr 8 mo	U-1356