Duopa

Treats motor fluctuations. NDA 203952, held by Abbvie. Carbidopa; Levodopa.

As of Nov 13, 2026, NDA 203952 (Duopa), held by Abbvie, was first approved by FDA on Jan 9, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 9, 2015
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DUOPA is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 9, 2015	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Duopa4.63MG/ML;20MG/ML · suspension;enteral	Carbidopa; Levodopa	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Mar 19, 2026	Supplement 14Labeling · Standard review	Approved	Label Letter
May 21, 2020	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 5, 2019	Supplement 10Labeling · Standard review	Approved	Letter Label
Sep 15, 2016	Supplement 4Labeling · Standard review	Approved	Letter Label
Jan 26, 2016	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 21, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
May 22, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 9, 2015	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 203952
Drugs@FDA: Overview at FDA
Company: AbbVie

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