Carvedilol

ANDA 77474, held by Chartwell Molecular. Carvedilol.

As of Nov 15, 2026, ANDA 77474 (Carvedilol), held by Chartwell Molecular, was first approved by FDA on Sep 5, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2007
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
Sep 5, 2007	Original application	Approved	Letter

Products

4 strengths and forms


Carvedilol3.125MG · tablet;oral	Carvedilol	Rx
Carvedilol6.25MG · tablet;oral	Carvedilol	Rx
Carvedilol12.5MG · tablet;oral	Carvedilol	Rx
Carvedilol25MG · tablet;oral	Carvedilol	Rx

All 3 submissions, including labeling and manufacturing supplements


Mar 3, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Mar 25, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 77474
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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