Captopril

ANDA 74462, held by Cosette Pharms Nc. Captopril.

As of Nov 13, 2026, ANDA 74462 (Captopril), held by Cosette Pharms Nc, 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
Mar 23, 1999	Supplement 4Manufacturing	Approved	None posted
Nov 5, 1997	Supplement 3Labeling	Approved	None posted
Jun 24, 1997	Supplement 2Labeling	Approved	None posted
Dec 27, 1996	Supplement 1Manufacturing	Approved	None posted
Feb 13, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74462
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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