Orange Book product · Brand (NDA)

UTIBRON NEOHALER

GLYCOPYRROLATE; INDACATEROL MALEATE

Brand (NDA)NDA 207930DISCN NOVARTIS

Oct 29, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 29, 2015
10 yr 10 mo ago
Today
Patent 8479730 expires
Listed drug product patent expiration.
Oct 11, 2028
in 2 yr 4 mo
Patent 8182838 expires
Listed drug product patent expiration.
Oct 20, 2028
in 2 yr 4 mo

Active ingredient

GLYCOPYRROLATE; INDACATEROL MALEATE

Strength

15.6MCG/INH;27.5MCG/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 207930

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8479730	Oct 11, 2028	in 2 yr 4 mo	Product
8182838	Oct 20, 2028	in 2 yr 4 mo	Product