Accuneb

NDA 20949, held by Pharmobedient. Albuterol Sulfate.

As of Nov 14, 2026, NDA 20949 (Accuneb), held by Pharmobedient, was first approved by FDA on Apr 30, 2001, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2001
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 30, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

2 strengths and forms


AccunebEQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Albuterol Sulfate	DiscontinuedReference drug
AccunebEQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Albuterol Sulfate	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Apr 28, 2022	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 30, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 30, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 2, 2011	Supplement 24Labeling	Approved	Label Letter
Jun 2, 2006	Supplement 11Labeling · Standard review	Approved	Letter Patient Information Sheet
Nov 13, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 6, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 20, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 20, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 22, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 22, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 30, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 20949
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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