Vancenase Aq

NDA 20469, held by Schering. Beclomethasone Dipropionate Monohydrate.

As of Nov 13, 2026, NDA 20469 (Vancenase Aq), held by Schering, was first approved by FDA on Jun 26, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 26, 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
Jun 26, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vancenase AqEQ 0.084MG DIPROP/SPRAY · spray, metered;nasal	Beclomethasone Dipropionate Monohydrate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jun 11, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 30, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 28, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 14, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 13, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Feb 13, 1997	Supplement 3Labeling · Standard review	Approved	None posted
Jun 26, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20469
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