Captopril

ANDA 74363, held by Chartwell Rx. Captopril.

As of Nov 13, 2026, ANDA 74363 (Captopril), held by Chartwell Rx, was first approved by FDA on Nov 9, 1995, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1995
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Nov 9, 1995	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 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 27, 2009	Supplement 14Labeling	Approved	None posted
Dec 5, 2008	Supplement 13Labeling	Approved	None posted
Oct 29, 2008	Supplement 12Labeling	Approved	None posted
May 14, 2004	Supplement 9Labeling	Approved	None posted
Mar 25, 2002	Supplement 8Manufacturing	Approved	None posted
May 2, 2001	Supplement 7Manufacturing	Approved	None posted
Apr 22, 1999	Supplement 6Manufacturing	Approved	None posted
Feb 12, 1998	Supplement 5Labeling	Approved	None posted
Nov 5, 1997	Supplement 4Labeling	Approved	None posted
Aug 11, 1997	Supplement 3Manufacturing	Approved	None posted
Jun 5, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 21, 1996	Supplement 1Manufacturing	Approved	None posted
Nov 9, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74363
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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