Beclovent

NDA 18153, held by Glaxosmithkline. Beclomethasone Dipropionate.

As of Nov 13, 2026, NDA 18153 (Beclovent), held by Glaxosmithkline, was first approved by FDA on Jun 24, 1980, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 24, 1980
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 24, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Beclovent0.042MG/INH · aerosol, metered;inhalation	Beclomethasone Dipropionate	Discontinued

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 10, 1997	Supplement 22Labeling · Standard review	Approved	None posted
Nov 19, 1993	Supplement 16Labeling · Standard review	Approved	None posted
Jul 6, 1993	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 10, 1992	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 27, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 15, 1988	Supplement 15Labeling · Standard review	Approved	None posted
Dec 15, 1988	Supplement 5Labeling · Standard review	Approved	None posted
Feb 16, 1988	Supplement 4Labeling · Standard review	Approved	None posted
Feb 16, 1988	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 6, 1987	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 13, 1985	Supplement 9Labeling · Standard review	Approved	None posted
Sep 10, 1985	Supplement 11Labeling · Standard review	Approved	None posted
Sep 10, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 15, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 19, 1982	Supplement 2Labeling · Standard review	Approved	None posted
Jan 19, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 24, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18153
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