Carvedilol

ANDA 78217, held by Lupin. Carvedilol.

As of Nov 15, 2026, ANDA 78217 (Carvedilol), held by Lupin, was first approved by FDA on Sep 5, 2007, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2007
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 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 5 submissions, including labeling and manufacturing supplements


Nov 1, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Mar 12, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Mar 12, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jun 26, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 78217
Drugs@FDA: Overview at FDA
Company: Lupin

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