Xopenex

NDA 20837, held by Hikma. Levalbuterol Hydrochloride.

As of Nov 13, 2026, NDA 20837 (Xopenex), held by Hikma, was first approved by FDA on Mar 25, 1999, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1999
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Jan 22, 2015	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jan 30, 2002	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label
Mar 25, 1999	Original applicationNew dosage form · Standard review	Approved	Label Review Letter

Products

4 strengths and forms


XopenexEQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Levalbuterol Hydrochloride	DiscontinuedReference drug
XopenexEQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Levalbuterol Hydrochloride	DiscontinuedReference drug
XopenexEQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Levalbuterol Hydrochloride	DiscontinuedReference drug
XopenexEQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Levalbuterol Hydrochloride	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Jan 3, 2019	Supplement 44Labeling · Standard review	Approved	Label Letter
Mar 31, 2015	Supplement 43Labeling · Standard review	Approved	Label Letter
Jan 22, 2015	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 15, 2014	Supplement 42Manufacturing · Standard review	Approved	None posted
Mar 31, 2014	Supplement 39Labeling · Standard review	Approved	Letter Label
Jan 15, 2014	Supplement 40Labeling · Standard review	Approved	Letter
Sep 20, 2013	Supplement 38Labeling · Standard review	Approved	Label Letter
Jan 9, 2013	Supplement 37Manufacturing · Standard review	Approved	None posted
Jan 9, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Sep 7, 2012	Supplement 36Labeling	Approved	Label Letter
Sep 7, 2006	Supplement 20Labeling · Standard review	Approved	Letter
Jul 18, 2003	Supplement 10Manufacturing · Standard review	Approved	Review Letter
Aug 7, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 4, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 30, 2002	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label
Feb 16, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 4, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 21, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 25, 1999	Original applicationNew dosage form · Standard review	Approved	Label Review Letter

Identifiers

Application: NDA 20837
Drugs@FDA: Overview at FDA
Company: Hikma

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