Quinapril Hydrochloride And Hydrochlorothiazide

ANDA 78450, held by Aurobindo Pharma. Hydrochlorothiazide; Quinapril Hydrochloride.

First approved: Aug 24, 2007
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Aug 24, 2007	Original application	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 10MG BASE · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Rx
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 20MG BASE · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Rx
Quinapril Hydrochloride And Hydrochlorothiazide25MG;EQ 20MG BASE · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Rx

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 26, 2022	Supplement 26Labeling · Standard review	Approved	None posted
May 26, 2022	Supplement 24Labeling · Standard review	Approved	None posted
May 26, 2022	Supplement 21Labeling · Standard review	Approved	None posted
May 26, 2022	Supplement 17Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Apr 26, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 6Labeling	Approved	None posted
Nov 28, 2011	Supplement 5Labeling	Approved	None posted
Aug 2, 2011	Supplement 4Labeling	Approved	None posted
Jul 30, 2010	Supplement 2Labeling	Approved	None posted
Aug 24, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78450
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters