Beconase

NDA 18584, held by Glaxosmithkline. Beclomethasone Dipropionate.

As of Nov 13, 2026, NDA 18584 (Beconase), held by Glaxosmithkline, was first approved by FDA on Sep 30, 1981, with 22 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1981
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Nov 1, 1985	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 30, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Beconase0.042MG/INH · aerosol, metered;nasal	Beclomethasone Dipropionate	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Dec 16, 2002	Supplement 26Labeling · Standard review	Approved	Letter
Feb 20, 2002	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 31, 2001	Supplement 27Labeling · Standard review	Approved	Label
Apr 4, 1996	Supplement 25Labeling · Standard review	Approved	None posted
Mar 12, 1996	Supplement 23Labeling · Standard review	Approved	None posted
Nov 19, 1993	Supplement 18Labeling · Standard review	Approved	None posted
Jul 6, 1993	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 10, 1992	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 27, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 15, 1988	Supplement 16Labeling · Standard review	Approved	None posted
Feb 24, 1988	Supplement 4Labeling · Standard review	Approved	None posted
Feb 16, 1988	Supplement 2Labeling · Standard review	Approved	None posted
Feb 16, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 2, 1987	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 6, 1987	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 1, 1985	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 1, 1985	Supplement 8Labeling · Standard review	Approved	None posted
Oct 4, 1985	Supplement 11Labeling · Standard review	Approved	None posted
Oct 4, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 15, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 30, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18584
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