Hexadrol

NDA 12674, held by Aspen Global Inc. Dexamethasone.

As of Nov 13, 2026, NDA 12674 (Hexadrol), held by Aspen Global Inc, was first approved by FDA on Dec 21, 1960, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1960
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 21, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hexadrol0.5MG/5ML · elixir;oral	Dexamethasone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 10Labeling · Standard review	Approved	Letter Label
May 11, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 2, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 18, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 21, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12674
Drugs@FDA: Overview at FDA
Company: Aspen Global Inc

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