Desoxyn

NDA 5378, held by Ajenat Pharms. Methamphetamine Hydrochloride.

As of Nov 13, 2026, NDA 5378 (Desoxyn), held by Ajenat Pharms, was first approved by FDA on Dec 31, 1943, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1943
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Dec 31, 1943	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Desoxyn5MG · tablet;oral	Methamphetamine Hydrochloride	RxReference drug
Desoxyn10MG · tablet, extended release;oral	Methamphetamine Hydrochloride	Discontinued
Desoxyn5MG · tablet, extended release;oral	Methamphetamine Hydrochloride	Discontinued
Desoxyn15MG · tablet, extended release;oral	Methamphetamine Hydrochloride	Discontinued

All 27 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 24, 2024	Supplement 32Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 38Labeling · Standard review	Approved	Label Letter
Feb 25, 2022	Supplement 37Labeling	Approved	Label Letter
Apr 11, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
May 19, 2017	Supplement 34Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 31Labeling	Approved	Letter Label
Apr 17, 2015	Supplement 30Labeling	Approved	Letter Label
Jan 26, 2015	Supplement 29Manufacturing	Approved	None posted
Dec 3, 2013	Supplement 28Labeling · Standard review	Approved	Letter Label
Aug 23, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
May 11, 2007	Supplement 26Labeling · Standard review	Approved	Letter Label
Apr 12, 2006	Supplement 24Labeling · Standard review	Approved	Letter Label
Dec 6, 2001	Supplement 20Labeling · Standard review	Approved	Label
Nov 20, 2000	Supplement 23Manufacturing	Approved	None posted
Jun 16, 1999	Supplement 22Manufacturing	Approved	None posted
May 13, 1998	Supplement 21Manufacturing	Approved	None posted
Jul 27, 1989	Supplement 19Manufacturing	Approved	None posted
Feb 22, 1984	Supplement 13Labeling	Approved	None posted
Jun 27, 1983	Supplement 15Labeling	Approved	None posted
Apr 25, 1983	Supplement 16Labeling	Approved	None posted
Sep 22, 1982	Supplement 14Manufacturing	Approved	None posted
Sep 30, 1981	Supplement 11Manufacturing	Approved	None posted
Mar 30, 1979	Supplement 9Labeling	Approved	None posted
Jul 22, 1975	Supplement 6Labeling	Approved	None posted
Jul 22, 1975	Supplement 5Manufacturing	Approved	None posted
Jul 22, 1975	Supplement 3Labeling	Approved	None posted
Dec 31, 1943	Original application	Approved	None posted

Identifiers

Application: NDA 5378
Drugs@FDA: Overview at FDA
Company: Ajenat Pharmaceuticals

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