Harmonyl

As of Nov 13, 2026, NDA 10796 (Harmonyl), held by Abbvie, was first approved by FDA on Apr 19, 1957, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 19, 1957
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 19, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Harmonyl0.1MG · tablet;oral	Deserpidine	Discontinued
Harmonyl0.25MG · tablet;oral	Deserpidine	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 7Labeling	Approved	None posted
Sep 25, 1991	Supplement 11Labeling	Approved	None posted
Mar 5, 1984	Supplement 13Labeling	Approved	None posted
Dec 15, 1983	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 16, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 16, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 28, 1980	Supplement 8Labeling	Approved	None posted
Apr 19, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10796
Drugs@FDA: Overview at FDA
Company: AbbVie

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