Captopril And Hydrochlorothiazide

Treats hypertension. ANDA 74896, held by Rising. Captopril; Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 74896 (Captopril And Hydrochlorothiazide), held by Rising, 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

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.

Full prescribing information on DailyMed ↗

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

All 8 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 31Labeling · Standard review	Approved	None posted
Jul 30, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Aug 14, 2006	Supplement 7Labeling	Approved	None posted
Aug 21, 2002	Supplement 4Manufacturing	Approved	None posted
Sep 5, 2001	Supplement 3Manufacturing	Approved	None posted
Aug 25, 2000	Supplement 2Labeling	Approved	None posted
Aug 11, 2000	Supplement 1Manufacturing	Approved	None posted
Dec 29, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74896
Drugs@FDA: Overview at FDA
Company: Rising 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