Selegiline Hydrochloride

ANDA 74744, held by Cosette Pharms Nc. Selegiline Hydrochloride.

As of Nov 15, 2026, ANDA 74744 (Selegiline Hydrochloride), held by Cosette Pharms Nc, was first approved by FDA on Jan 27, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1997
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
Jan 27, 1997	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


Dec 2, 1999	Supplement 8Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 9Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 3Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 4Manufacturing	Approved	None posted
Sep 28, 1998	Supplement 2Labeling	Approved	None posted
Jun 18, 1997	Supplement 1Labeling	Approved	None posted
Jan 27, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74744
Drugs@FDA: Overview at FDA
Company: Cosette 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