Selegiline Hydrochloride

ANDA 74641, held by Chartwell Molecules. Selegiline Hydrochloride.

As of Nov 15, 2026, ANDA 74641 (Selegiline Hydrochloride), held by Chartwell Molecules, was first approved by FDA on Aug 2, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 2, 1996
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 2, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Selegiline Hydrochloride5MG · tablet;oral	Selegiline Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jul 25, 2001	Supplement 5Manufacturing	Approved	None posted
Jul 25, 2001	Supplement 6Manufacturing	Approved	None posted
Aug 31, 1999	Supplement 4Labeling	Approved	None posted
Sep 18, 1998	Supplement 3Manufacturing	Approved	None posted
Apr 8, 1998	Supplement 2Labeling	Approved	None posted
Jul 11, 1997	Supplement 1Labeling	Approved	None posted
Aug 2, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74641
Drugs@FDA: Overview at FDA
Company: Chartwell Molecules

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