Captopril

ANDA 74493, held by Strides Pharma Intl. Captopril.

As of Nov 13, 2026, ANDA 74493 (Captopril), held by Strides Pharma Intl, was first approved by FDA on Feb 13, 1996, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1996
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 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 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 24, 1998	Supplement 4Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 1Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 3, 1997	Supplement 3Labeling	Approved	None posted
Feb 13, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74493
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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