Exelon

Treats dementia of the Alzheimer’s type (AD). NDA 22083, held by Sandoz. Rivastigmine.

As of Nov 14, 2026, NDA 22083 (Exelon), held by Sandoz, was first approved by FDA on Jul 6, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 6, 2007
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of:

Mild, moderate, and severe dementia of the Alzheimer’s type (AD).
Mild-to-moderate dementia associated with Parkinson’s disease (PD). 1.1 Alzheimer’s Disease EXELON PATCH is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. 1.2 Parkinson’s Disease Dementia EXELON PATCH is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jun 27, 2013	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 31, 2012	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 6, 2007	Original applicationNew dosage form · Standard review	Approved	Review Label

Products

3 strengths and forms


Exelon4.6MG/24HR · film, extended release;transdermal	Rivastigmine	RxReference drug
Exelon9.5MG/24HR · film, extended release;transdermal	Rivastigmine	RxReference drug
Exelon13.3MG/24HR · film, extended release;transdermal	Rivastigmine	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


May 8, 2024	Supplement 28Labeling · Standard review	Approved	Label Letter
Dec 18, 2018	Supplement 26Labeling · Standard review	Approved	Letter Label
Nov 2, 2016	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 24, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 27, 2013	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 13, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 31, 2012	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Aug 27, 2010	Supplement 8Labeling	Approved	Label Letter
Jul 6, 2007	Original applicationNew dosage form · Standard review	Approved	Review Label

Identifiers

Application: NDA 22083
Drugs@FDA: Overview at FDA
Company: Sandoz

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