Decadron

NDA 12376, held by Merck. Dexamethasone.

As of Nov 13, 2026, NDA 12376 (Decadron), held by Merck, was first approved by FDA on Jul 7, 1960, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 7, 1960
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 7, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Decadron0.5MG/5ML · elixir;oral	Dexamethasone	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 27, 1993	Supplement 28Labeling · Standard review	Approved	None posted
May 16, 1989	Supplement 22Labeling · Standard review	Approved	None posted
Jan 12, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
May 21, 1982	Supplement 18Labeling · Standard review	Approved	None posted
Feb 10, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 15, 1979	Supplement 17Labeling · Standard review	Approved	None posted
Mar 1, 1979	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 7, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12376
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