Vancenase

NDA 18521, held by Schering. Beclomethasone Dipropionate.

As of Nov 14, 2026, NDA 18521 (Vancenase), held by Schering, was first approved by FDA on Sep 24, 1981, with 26 approved supplements and 0 published complete response letters.

First approved: Sep 24, 1981
Review: Priority
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Nov 2, 1985	Supplement 11Efficacy (new indication or use) · Priority review	Approved	None posted
Sep 24, 1981	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vancenase0.042MG/INH · aerosol, metered;nasal	Beclomethasone Dipropionate	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Aug 30, 2000	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 26, 2000	Supplement 31Manufacturing · Priority review	Approved	None posted
Mar 11, 1999	Supplement 29Manufacturing · Priority review	Approved	None posted
Mar 3, 1997	Supplement 25Labeling · Priority review	Approved	None posted
Feb 3, 1997	Supplement 24Labeling · Priority review	Approved	None posted
Aug 3, 1995	Supplement 26Manufacturing · Priority review	Approved	None posted
Dec 15, 1988	Supplement 23Labeling · Priority review	Approved	None posted
Aug 4, 1988	Supplement 20Labeling · Priority review	Approved	None posted
Aug 2, 1988	Supplement 21Manufacturing · Priority review	Approved	None posted
May 9, 1988	Supplement 6Labeling · Priority review	Approved	None posted
Feb 1, 1988	Supplement 18Manufacturing · Priority review	Approved	None posted
Sep 24, 1987	Supplement 19Manufacturing · Priority review	Approved	None posted
Jul 8, 1986	Supplement 17Manufacturing · Priority review	Approved	None posted
Mar 6, 1986	Supplement 16Manufacturing · Priority review	Approved	None posted
Feb 24, 1986	Supplement 15Labeling · Priority review	Approved	None posted
Feb 24, 1986	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 2, 1985	Supplement 13Labeling · Priority review	Approved	None posted
Nov 2, 1985	Supplement 11Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 21, 1985	Supplement 10Manufacturing · Priority review	Approved	None posted
Jan 2, 1985	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 17, 1984	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 4, 1982	Supplement 5Manufacturing · Priority review	Approved	None posted
Feb 4, 1982	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 3, 1981	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 6, 1981	Supplement 2Labeling · Priority review	Approved	None posted
Nov 6, 1981	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 24, 1981	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18521
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