Decadron

NDA 11983, held by Merck. Dexamethasone Sodium Phosphate.

As of Nov 13, 2026, NDA 11983 (Decadron), held by Merck, was first approved by FDA on Aug 26, 1959, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1959
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
Aug 26, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DecadronEQ 0.1% PHOSPHATE · cream;topical	Dexamethasone Sodium Phosphate	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 25, 1997	Supplement 16Labeling	Approved	None posted
Jun 25, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Jun 25, 1997	Supplement 18Labeling · Standard review	Approved	None posted
Aug 5, 1983	Supplement 15Labeling	Approved	None posted
Sep 11, 1978	Supplement 14Labeling	Approved	None posted
Aug 9, 1977	Supplement 13Labeling	Approved	None posted
Aug 26, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11983
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