Carvedilol

ANDA 77316, held by Sciegen Pharms. Carvedilol.

As of Nov 15, 2026, ANDA 77316 (Carvedilol), held by Sciegen Pharms, was first approved by FDA on Sep 5, 2007, with 7 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 5, 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 8 submissions, including labeling and manufacturing supplements


Jul 23, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Mar 3, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Apr 4, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Jun 13, 2013	Supplement 6Labeling	Approved	None posted
Apr 21, 2011	Supplement 5Labeling	Approved	None posted
Feb 14, 2011	Supplement 3Labeling	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 77316
Drugs@FDA: Overview at FDA
Company: ScieGen Pharmaceuticals

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