Desyrel

NDA 18207, held by Pragma. Trazodone Hydrochloride.

As of Nov 13, 2026, NDA 18207 (Desyrel), held by Pragma, was first approved by FDA on Dec 24, 1981, with 29 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1981
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Nov 7, 1988	Supplement 14Efficacy (new indication or use)	Approved	None posted
Sep 2, 1986	Supplement 12Efficacy (new indication or use)	Approved	None posted
Dec 24, 1981	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Desyrel50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trazodone Hydrochloride	DiscontinuedReference drug
Desyrel100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trazodone Hydrochloride	DiscontinuedReference drug
Desyrel150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trazodone Hydrochloride	DiscontinuedReference drug
Desyrel300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trazodone Hydrochloride	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 24, 2025	Supplement 37Labeling · Standard review	Approved	Label Letter
Oct 18, 2018	Supplement 33Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 30, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 17, 2014	Supplement 31Labeling	Approved	Letter
Jan 12, 2005	Supplement 30Labeling · Standard review	Approved	Letter Label
Mar 17, 2004	Supplement 29Labeling · Standard review	Approved	Letter
Apr 14, 2000	Supplement 23Labeling · Standard review	Approved	None posted
Apr 14, 2000	Supplement 13Labeling	Approved	None posted
Jun 25, 1996	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 25, 1996	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 21, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 7, 1996	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 5, 1990	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 7, 1988	Supplement 14Efficacy (new indication or use)	Approved	None posted
Oct 26, 1988	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 14, 1988	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 22, 1988	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 3, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 3, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 2, 1986	Supplement 12Efficacy (new indication or use)	Approved	None posted
Feb 26, 1986	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 27, 1985	Supplement 7Labeling	Approved	None posted
Sep 19, 1985	Supplement 10Labeling	Approved	None posted
Jul 10, 1985	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 25, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 29, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 24, 1983	Supplement 6Labeling	Approved	None posted
Apr 4, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 1, 1982	Supplement 1Labeling	Approved	None posted
Dec 24, 1981	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18207
Drugs@FDA: Overview at FDA
Company: Pragma

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