Captopril And Hydrochlorothiazide

ANDA 74827, held by Cosette Pharms Nc. Captopril; Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 74827 (Captopril And Hydrochlorothiazide), held by Cosette Pharms Nc, was first approved by FDA on Dec 29, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 29, 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
Dec 29, 1997	Original application	Approved	None posted

Products

4 strengths and forms


Captopril And Hydrochlorothiazide25MG;15MG · tablet;oral	Captopril; Hydrochlorothiazide	Discontinued
Captopril And Hydrochlorothiazide25MG;25MG · tablet;oral	Captopril; Hydrochlorothiazide	Discontinued
Captopril And Hydrochlorothiazide50MG;25MG · tablet;oral	Captopril; Hydrochlorothiazide	Discontinued
Captopril And Hydrochlorothiazide50MG;15MG · tablet;oral	Captopril; Hydrochlorothiazide	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Oct 30, 2009	Supplement 17Labeling	Approved	None posted
Nov 29, 2006	Supplement 14Labeling	Approved	None posted
Aug 30, 2001	Supplement 4Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 2Manufacturing	Approved	None posted
May 15, 2000	Supplement 3Labeling	Approved	None posted
Mar 22, 1999	Supplement 1Manufacturing	Approved	None posted
Dec 29, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74827
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