Decadron

NDA 11984, held by Merck. Dexamethasone Sodium Phosphate.

As of Nov 14, 2026, NDA 11984 (Decadron), held by Merck, was first approved by FDA on Sep 2, 1959, with 30 approved supplements and 0 published complete response letters.

First approved: Sep 2, 1959
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Sep 2, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DecadronEQ 0.1% PHOSPHATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic, otic	Dexamethasone Sodium Phosphate	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Aug 29, 1997	Supplement 45Manufacturing · Standard review	Approved	None posted
Jul 31, 1997	Supplement 46Manufacturing · Standard review	Approved	None posted
Mar 4, 1997	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Supplement 42Manufacturing · Standard review	Approved	None posted
Apr 25, 1995	Supplement 41Manufacturing · Standard review	Approved	None posted
Dec 22, 1994	Supplement 40Manufacturing · Standard review	Approved	None posted
Oct 21, 1994	Supplement 39Labeling · Standard review	Approved	None posted
Apr 18, 1991	Supplement 36Labeling · Standard review	Approved	None posted
Oct 17, 1988	Supplement 34Labeling · Standard review	Approved	None posted
Oct 17, 1988	Supplement 30Labeling · Standard review	Approved	None posted
Feb 16, 1988	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 16, 1988	Supplement 33Labeling · Standard review	Approved	None posted
Feb 16, 1988	Supplement 25Labeling · Standard review	Approved	None posted
Feb 25, 1986	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 12, 1986	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 6, 1984	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 14, 1984	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 15, 1982	Supplement 26Labeling · Standard review	Approved	None posted
May 14, 1982	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 27, 1981	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 9, 1981	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 15, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 1, 1980	Supplement 22Labeling · Standard review	Approved	None posted
Sep 17, 1980	Supplement 19Manufacturing · Standard review	Approved	None posted
May 28, 1980	Supplement 18Labeling · Standard review	Approved	None posted
Jan 8, 1980	Supplement 16Labeling · Standard review	Approved	None posted
Aug 26, 1979	Supplement 17Labeling · Standard review	Approved	None posted
May 19, 1976	Supplement 15Labeling · Standard review	Approved	None posted
Apr 21, 1976	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 2, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11984
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