Captopril

ANDA 74532, held by Wockhardt Bio AG. Captopril.

As of Nov 13, 2026, ANDA 74532 (Captopril), held by Wockhardt Bio AG, was first approved by FDA on Mar 28, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1997
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
Mar 28, 1997	Original application	Approved	None posted

Products

4 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 11, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 11, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 30, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Apr 22, 2002	Supplement 2Manufacturing	Approved	None posted
Apr 22, 2002	Supplement 3Manufacturing	Approved	None posted
Sep 5, 1997	Supplement 1Labeling	Approved	None posted
Mar 28, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74532
Drugs@FDA: Overview at FDA
Company: Wockhardt Bio AG

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