Dexacort

NDA 13413, held by Ucb Inc. Dexamethasone Sodium Phosphate.

As of Nov 13, 2026, NDA 13413 (Dexacort), held by Ucb Inc, was first approved by FDA on Sep 17, 1962, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 17, 1962
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
Sep 17, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DexacortEQ 0.1MG PHOSPHATE/INH · aerosol, metered;inhalation	Dexamethasone Sodium Phosphate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jul 10, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
May 3, 1994	Supplement 26Labeling · Standard review	Approved	None posted
Sep 11, 1991	Supplement 25Manufacturing · Standard review	Approved	None posted
May 18, 1989	Supplement 21Labeling · Standard review	Approved	None posted
Aug 15, 1979	Supplement 15Labeling · Standard review	Approved	None posted
Aug 6, 1979	Supplement 14Labeling · Standard review	Approved	None posted
Sep 17, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 13413
Drugs@FDA: Overview at FDA
Company: UCB

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