Azilect

Treats Parkinson’s disease (PD). NDA 21641, held by Teva. Rasagiline Mesylate.

As of Nov 14, 2026, NDA 21641 (Azilect), held by Teva, was first approved by FDA on May 16, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: May 16, 2006
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


May 29, 2014	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Summary Review Review Label
May 16, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


AzilectEQ 0.5MG BASE · tablet;oral	Rasagiline Mesylate	RxReference drug
AzilectEQ 1MG BASE · tablet;oral	Rasagiline Mesylate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 16, 2020	Supplement 21Labeling · Standard review	Approved	Letter Label
Dec 20, 2018	Supplement 20Labeling · Standard review	Approved	Label
Dec 9, 2015	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 20, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
May 29, 2014	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 29, 2014	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Summary Review Review Label
Dec 9, 2009	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 5Labeling · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 9, 2009	Supplement 2Labeling · Standard review	Approved	Letter Label
May 16, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21641
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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