Captopril

ANDA 74434, held by Aurobindo Pharma USA. Captopril.

As of Nov 13, 2026, ANDA 74434 (Captopril), held by Aurobindo Pharma USA, was first approved by FDA on Feb 13, 1996, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1996
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Feb 13, 1996	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Captopril12.5MG · tablet;oral	Captopril	Discontinued
Captopril25MG · tablet;oral	Captopril	Discontinued
Captopril50MG · tablet;oral	Captopril	Discontinued
Captopril100MG · tablet;oral	Captopril	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 3, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Nov 9, 2015	Supplement 15Labeling · Standard review	Approved	None posted
Apr 22, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Apr 22, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Jul 19, 2004	Supplement 7Labeling	Approved	None posted
Apr 22, 2002	Supplement 6Manufacturing	Approved	None posted
Nov 13, 2001	Supplement 5Manufacturing	Approved	None posted
Dec 13, 1999	Supplement 4Labeling	Approved	None posted
Feb 27, 1998	Supplement 3Labeling	Approved	None posted
Oct 30, 1997	Supplement 1Manufacturing	Approved	None posted
Oct 14, 1997	Supplement 2Labeling	Approved	None posted
Feb 13, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74434
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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