Quinapril Hydrochloride And Hydrochlorothiazide

ANDA 91524, held by Apotex. Hydrochlorothiazide; Quinapril Hydrochloride.

First approved: Mar 12, 2013
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 12, 2013	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	Discontinued
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 20MG BASE · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Discontinued
Quinapril Hydrochloride And Hydrochlorothiazide25MG;EQ 20MG BASE · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 27, 2022	Supplement 13Labeling · Standard review	Approved	None posted
May 27, 2022	Supplement 12Labeling · Standard review	Approved	None posted
May 27, 2022	Supplement 11Labeling · Standard review	Approved	None posted
May 27, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Mar 12, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91524
Drugs@FDA: Overview at FDA
Company: Apotex

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