Entacapone

ANDA 203437, held by Aurobindo Pharma Ltd. Entacapone.

As of Nov 14, 2026, ANDA 203437 (Entacapone), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 19, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 19, 2015
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Entacapone tablets, USP are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies ). Entacapone tablets, USP effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 19, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Entacapone200MG · tablet;oral	Entacapone	Rx

All 2 submissions, including labeling and manufacturing supplements


Mar 30, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jun 19, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203437
Drugs@FDA: Overview at FDA
Company: Aurobindo 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