Vanceril Double Strength

NDA 20486, held by Schering. Beclomethasone Dipropionate.

As of Nov 14, 2026, NDA 20486 (Vanceril Double Strength), held by Schering, was first approved by FDA on Dec 24, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1996
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 24, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vanceril Double Strength0.084MG/INH · aerosol, metered;inhalation	Beclomethasone Dipropionate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 5Labeling · Standard review	Approved	None posted
Aug 30, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 26, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 16, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 21, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 24, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20486
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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