Captopril

ANDA 74576, held by Watson Labs. Captopril.

As of Nov 13, 2026, ANDA 74576 (Captopril), held by Watson Labs, was first approved by FDA on Apr 23, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 23, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 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 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 6, 1998	Supplement 5Labeling	Approved	None posted
Oct 30, 1997	Supplement 3Manufacturing	Approved	None posted
Oct 30, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 30, 1997	Supplement 1Manufacturing	Approved	None posted
Jul 11, 1997	Supplement 4Labeling	Approved	None posted
Apr 23, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74576
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