Utibron Neohaler

NDA 207930, held by Novartis. Glycopyrrolate; Indacaterol Maleate.

As of Nov 13, 2026, NDA 207930 (Utibron Neohaler), held by Novartis, was first approved by FDA on Oct 29, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2015
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 29, 2015	Original applicationTYPE 3/4 · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Utibron Neohaler15.6MCG/INH;27.5MCG/INH · powder;inhalation	Glycopyrrolate; Indacaterol Maleate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Jul 30, 2021	Supplement 5Labeling · Standard review	Approved	Label Letter
Jul 30, 2021	Supplement 6Labeling · Standard review	Approved	Label Letter
May 29, 2019	Supplement 4Labeling · Standard review	Approved	Letter Label
Jan 25, 2017	Supplement 2Labeling · Standard review	Approved	Letter Label
May 11, 2016	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 29, 2015	Original applicationTYPE 3/4 · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 207930
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters