Xopenex Hfa

Prevents bronchospasm. NDA 21730, held by Lupin. Levalbuterol Tartrate.

As of Nov 14, 2026, NDA 21730 (Xopenex Hfa), held by Lupin, was first approved by FDA on Mar 11, 2005, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 11, 2005
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XOPENEX HFA is a beta 2 -adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.1 Bronchospasm

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Mar 12, 2015	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Medical Review
Mar 11, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xopenex HfaEQ 0.045MG BASE/INH · aerosol, metered;inhalation	Levalbuterol Tartrate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Feb 27, 2017	Supplement 39Labeling · Standard review	Approved	Label
Jan 22, 2016	Supplement 38Manufacturing · Standard review	Approved	None posted
Mar 12, 2015	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Medical Review
Aug 27, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Nov 25, 2013	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 10, 2013	Supplement 33Labeling · Standard review	Approved	Letter Label
Mar 14, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 9, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Dec 7, 2012	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 30, 2012	Supplement 24Labeling	Approved	Letter Label
Feb 5, 2008	Supplement 8Manufacturing	Approved	Label Letter
Sep 15, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Apr 4, 2006	Supplement 6Labeling · Standard review	Approved	Letter
Mar 11, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21730
Drugs@FDA: Overview at FDA
Company: Lupin

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