Carvedilol

ANDA 77887, held by Hikma. Carvedilol.

As of Nov 15, 2026, ANDA 77887 (Carvedilol), held by Hikma, was first approved by FDA on Sep 7, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 7, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 7, 2007	Original application	Approved	Letter

Products

4 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


May 7, 2013	Supplement 3Labeling	Approved	None posted
May 7, 2013	Supplement 4Labeling	Approved	None posted
May 7, 2013	Supplement 6Labeling	Approved	None posted
Feb 20, 2009	Supplement 2Labeling	Approved	None posted
Dec 22, 2008	Supplement 1Labeling	Approved	None posted
Sep 7, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 77887
Drugs@FDA: Overview at FDA
Company: Hikma

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