Seebri Neohaler

NDA 207923, held by Novartis. Glycopyrrolate.

As of Nov 13, 2026, NDA 207923 (Seebri Neohaler), held by Novartis, was first approved by FDA on Oct 29, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2015
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 29, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Seebri Neohaler15.6MCG/INH · powder;inhalation	Glycopyrrolate	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Jul 30, 2021	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 19, 2017	Supplement 2Labeling · Standard review	Approved	Letter Label
May 23, 2016	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 29, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 207923
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