Selegiline Hydrochloride

NDA 19334, held by Quagen. Selegiline Hydrochloride.

As of Nov 13, 2026, NDA 19334 (Selegiline Hydrochloride), held by Quagen, was first approved by FDA on Jun 5, 1989, with 13 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1989
Review: Priority
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jun 5, 1989	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Selegiline Hydrochloride5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Selegiline Hydrochloride	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 31, 2008	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 31, 2008	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 6, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Jul 13, 1994	Supplement 12Manufacturing · Priority review	Approved	None posted
Feb 12, 1993	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 5, 1993	Supplement 5Labeling	Approved	None posted
Jan 5, 1993	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 5, 1993	Supplement 7Labeling	Approved	None posted
Jan 5, 1993	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 5, 1993	Supplement 9Manufacturing · Priority review	Approved	None posted
Jul 25, 1990	Supplement 3Labeling	Approved	None posted
Mar 26, 1990	Supplement 1Labeling	Approved	None posted
Mar 1, 1990	Supplement 2Manufacturing · Priority review	Approved	None posted
Jun 5, 1989	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19334
Drugs@FDA: Overview at FDA
Company: Quagen 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