Eldepryl

NDA 20647, held by Quagen. Selegiline Hydrochloride.

As of Nov 14, 2026, NDA 20647 (Eldepryl), held by Quagen, was first approved by FDA on May 15, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: May 15, 1996
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 15, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eldepryl5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Selegiline Hydrochloride	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


May 20, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 31, 2008	Supplement 7Labeling · Standard review	Approved	Label Letter
Dec 31, 2008	Supplement 6Labeling · Standard review	Approved	Label Letter
Feb 15, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 6, 1997	Supplement 3Labeling · Standard review	Approved	Review
May 15, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20647
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