Carvedilol

ANDA 77346, held by Sun Pharm Inds Inc. Carvedilol.

As of Nov 15, 2026, ANDA 77346 (Carvedilol), held by Sun Pharm Inds Inc, 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 Label

Products

4 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Jun 1, 2016	Supplement 29Labeling · Standard review	Approved	None posted
Jun 1, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Apr 6, 2015	Supplement 5Labeling	Approved	None posted
May 10, 2013	Supplement 11Labeling	Approved	None posted
May 10, 2013	Supplement 15Labeling	Approved	None posted
Jan 31, 2011	Supplement 8Labeling	Approved	None posted
Jan 15, 2009	Supplement 4Labeling	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter Label

Identifiers

Application: ANDA 77346
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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