Orange Book product · Brand (NDA)

DUAKLIR PRESSAIR

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Brand (NDA)NDA 210595RX AZURITY

Mar 29, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 29, 2019
7 yr 4 mo ago
Today
Patent 10085974 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 11000517 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo

Active ingredient

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Strength

0.4MG/INH;0.012MG/INH

Dosage form

POWDER, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 210595

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
10085974	Mar 13, 2029	in 2 yr 9 mo	ProductU-2513
11000517	Mar 13, 2029	in 2 yr 9 mo	ProductU-2513