Decaspray

NDA 12731, held by Merck. Dexamethasone.

As of Nov 13, 2026, NDA 12731 (Decaspray), held by Merck, was first approved by FDA on Mar 29, 1961, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 29, 1961
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 29, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Decaspray0.04% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · aerosol;topical	Dexamethasone	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Nov 29, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 8, 1988	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 24, 1984	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 5, 1984	Supplement 11Labeling · Standard review	Approved	None posted
Feb 2, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 29, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12731
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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