Orange Book product · Brand (NDA)

ALVESCO

CICLESONIDE

Brand (NDA)NDA 021658RX COVIS

Jan 10, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 10, 2008
18 yr 9 mo ago
Today
Patent 8371292 expires
Listed method-of-use patent (U-1355) expiration.
Feb 01, 2028
in 1 yr 8 mo

Active ingredient

CICLESONIDE

Strength

0.16MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 021658

Product number

003

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-1355