Entacapone

ANDA 202394, held by Pharmobedient. Entacapone.

As of Nov 14, 2026, ANDA 202394 (Entacapone), held by Pharmobedient, was first approved by FDA on May 13, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: May 13, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 13, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Entacapone200MG · tablet;oral	Entacapone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 30, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jan 10, 2016	Supplement 1Labeling · Standard review	Approved	None posted
May 13, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202394
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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