Captopril

ANDA 74386, held by Watson Labs. Captopril.

As of Nov 13, 2026, ANDA 74386 (Captopril), held by Watson Labs, was first approved by FDA on May 23, 1996, with 7 approved supplements and 0 published complete response letters.

First approved: May 23, 1996
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
May 23, 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 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 25, 2001	Supplement 8Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 5Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 4Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 3Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 13, 1998	Supplement 2Labeling	Approved	None posted
Oct 21, 1997	Supplement 1Labeling	Approved	None posted
May 23, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74386
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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