Stalevo 50, Stalevo 100, Stalevo 150

Treats Parkinson's disease. NDA 21485, held by Orion Pharma. Carbidopa; Entacapone; Levodopa.

As of Nov 14, 2026, NDA 21485 (Stalevo 50, Stalevo 100, Stalevo 150), held by Orion Pharma, was first approved by FDA on Jun 11, 2003, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 11, 2003
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used:

To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.
To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 11, 2003	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

6 strengths and forms


Stalevo 5012.5MG;200MG;50MG · tablet;oral	Carbidopa; Entacapone; Levodopa	RxReference drug
Stalevo 10025MG;200MG;100MG · tablet;oral	Carbidopa; Entacapone; Levodopa	RxReference drug
Stalevo 15037.5MG;200MG;150MG · tablet;oral	Carbidopa; Entacapone; Levodopa	RxReference drug
Stalevo 20050MG;200MG;200MG · tablet;oral	Carbidopa; Entacapone; Levodopa	RxReference drug
Stalevo 7518.75MG;200MG;75MG · tablet;oral	Carbidopa; Entacapone; Levodopa	RxReference drug
Stalevo 12531.25MG;200MG;125MG · tablet;oral	Carbidopa; Entacapone; Levodopa	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Mar 19, 2026	Supplement 48Labeling · Standard review	Approved	Label Letter
Dec 30, 2019	Supplement 42Labeling · Standard review	Approved	Label Letter
Sep 21, 2018	Supplement 38	Approved	Label Letter
Feb 25, 2016	Supplement 36Manufacturing · Standard review	Approved	None posted
Feb 22, 2016	Supplement 33Labeling · Standard review	Approved	Label Letter
Feb 18, 2016	Supplement 35Manufacturing · Standard review	Approved	Label
Jan 29, 2016	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 29Labeling · Standard review	Approved	Letter Label
Jul 18, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Feb 14, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 16, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 5, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 11, 2010	Supplement 20Labeling · Standard review	Approved	Letter Label
Feb 2, 2009	Supplement 12Labeling · Standard review	Approved	Label Letter Label Letter
Feb 2, 2009	Supplement 8Labeling · Standard review	Approved	Label Letter Label Letter
Sep 26, 2008	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 29, 2008	Supplement 16Manufacturing	Approved	Letter Label
Aug 2, 2007	Supplement 11Manufacturing · Standard review	Approved	Letter Label
Jun 11, 2003	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21485
Drugs@FDA: Overview at FDA
Company: Orion 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