Serevent

NDA 20236, held by Glaxosmithkline. Salmeterol Xinafoate.

As of Nov 13, 2026, NDA 20236 (Serevent), held by Glaxosmithkline, was first approved by FDA on Feb 4, 1994, with 19 approved supplements and 0 published complete response letters.

First approved: Feb 4, 1994
Review: Priority
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 29, 2000	Supplement 19Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 5, 1998	Supplement 15Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 4, 1994	Original applicationNew molecular entity · Priority review	Approved	Pediatric Medical Review Pediatric Statistical Review Pediatric Written Request

Products

1 strengths and forms

Product	Active ingredient	Marketing
SereventEQ 0.021MG BASE/INH · aerosol, metered;inhalation	Salmeterol Xinafoate	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 28, 2004	Supplement 30Labeling · Priority review	Approved	Letter Label
Aug 11, 2003	Supplement 28Labeling · Priority review	Approved	Review Label Letter
Oct 16, 2001	Supplement 25Manufacturing · Priority review	Approved	None posted
May 17, 2001	Supplement 23Labeling · Priority review	Approved	None posted
Jun 29, 2000	Supplement 19Efficacy (new indication or use) · Priority review	Approved	None posted
Jun 15, 2000	Supplement 21Manufacturing · Priority review	Approved	None posted
Feb 25, 2000	Supplement 18Labeling · Priority review	Approved	None posted
Dec 24, 1998	Supplement 17Labeling · Priority review	Approved	Review
May 11, 1998	Supplement 16Labeling · Priority review	Approved	None posted
Feb 5, 1998	Supplement 15Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 26, 1997	Supplement 14Labeling · Priority review	Approved	None posted
Oct 15, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Aug 6, 1996	Supplement 13Manufacturing · Priority review	Approved	None posted
Jul 9, 1996	Supplement 1Labeling · Priority review	Approved	None posted
Nov 13, 1995	Supplement 11Manufacturing · Priority review	Approved	None posted
Jul 19, 1995	Supplement 10Manufacturing · Priority review	Approved	Review
Mar 14, 1995	Supplement 8Manufacturing · Priority review	Approved	None posted
Dec 23, 1994	Supplement 9Labeling · Priority review	Approved	None posted
Dec 23, 1994	Supplement 6Manufacturing · Priority review	Approved	None posted
Feb 4, 1994	Original applicationNew molecular entity · Priority review	Approved	Pediatric Medical Review Pediatric Statistical Review Pediatric Written Request

Identifiers

Application: NDA 20236
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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