Decadron

NDA 12071, held by Merck. Dexamethasone Sodium Phosphate.

As of Nov 13, 2026, NDA 12071 (Decadron), held by Merck, was first approved by FDA on Oct 6, 1959, with 12 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1959
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Oct 6, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


DecadronEQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dexamethasone Sodium Phosphate	DiscontinuedReference drug
DecadronEQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dexamethasone Sodium Phosphate	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Feb 18, 2000	Supplement 53Manufacturing · Standard review	Approved	None posted
Feb 17, 1999	Supplement 46Manufacturing · Standard review	Approved	None posted
Oct 22, 1997	Supplement 49Manufacturing · Standard review	Approved	None posted
Sep 9, 1997	Supplement 47Manufacturing · Standard review	Approved	None posted
Mar 1, 1996	Supplement 43Manufacturing · Standard review	Approved	None posted
Aug 26, 1993	Supplement 39Labeling · Standard review	Approved	None posted
Dec 11, 1989	Supplement 38Manufacturing · Standard review	Approved	None posted
Mar 8, 1985	Supplement 31Labeling · Standard review	Approved	None posted
Jun 25, 1984	Supplement 30Manufacturing · Standard review	Approved	None posted
Feb 5, 1981	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 15, 1979	Supplement 26Labeling · Standard review	Approved	None posted
Oct 18, 1978	Supplement 25Labeling · Standard review	Approved	None posted
Oct 6, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12071
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