Selegiline Hydrochloride

ANDA 74866, held by Novitium Pharma. Selegiline Hydrochloride.

As of Nov 15, 2026, ANDA 74866 (Selegiline Hydrochloride), held by Novitium Pharma, was first approved by FDA on Nov 26, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 26, 1997
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 26, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jan 5, 2010	Supplement 2Labeling	Approved	None posted
Nov 26, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74866
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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