Brovana

NDA 21912, held by Lupin. Arformoterol Tartrate.

As of Nov 14, 2026, NDA 21912 (Brovana), held by Lupin, was first approved by FDA on Oct 6, 2006, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2006
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


Feb 27, 2014	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Medication Guide Letter Label
Oct 6, 2006	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
BrovanaEQ 0.015MG BASE/2ML · solution;inhalation	Arformoterol Tartrate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


May 29, 2019	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 12, 2016	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 11, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 6, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 16, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 11, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 25, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 27, 2014	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Medication Guide Letter Label
Feb 26, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 14, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 9, 2012	Supplement 18	Approved	Letter
Aug 9, 2012	Supplement 20REMS	Approved	Letter
Sep 2, 2011	Supplement 16Labeling	Approved	Letter
Jul 14, 2011	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 16, 2011	Supplement 15Labeling	Approved	Label Letter
Feb 1, 2011	Supplement 12REMS	Approved	Letter
Jun 22, 2010	Supplement 8Labeling	Approved	None posted
Jun 2, 2010	Supplement 11Labeling	Approved	Letter Label
Dec 20, 2007	Supplement 1Manufacturing · Standard review	Approved	Letter Label
Oct 6, 2006	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 21912
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