Accuretic

NDA 20125, held by Pfizer Pharms. Hydrochlorothiazide; Quinapril Hydrochloride.

First approved: Dec 28, 1999
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 28, 1999	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Accuretic12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Discontinued · reference drug
Accuretic12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Discontinued · reference drug
Accuretic25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Quinapril Hydrochloride	Discontinued · reference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 19, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Aug 20, 2020	Supplement 27Labeling · Standard review	Approved	Label Letter
May 5, 2020	Supplement 25Labeling · Standard review	Approved	Label Letter
Apr 26, 2017	Supplement 22Labeling · Standard review	Approved	Letter Label
Jun 6, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 11, 2015	Supplement 20Labeling · Standard review	Approved	Label
Feb 5, 2015	Supplement 19Labeling · Standard review	Approved	Letter Label
May 2, 2014	Supplement 18Labeling · Standard review	Approved	Label Letter
Jan 17, 2014	Supplement 16Labeling · Standard review	Approved	Label Letter
Oct 25, 2013	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 23, 2013	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 19, 2012	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 21, 2012	Supplement 14Labeling · Standard review	Approved	Label Letter
Jan 18, 2012	Supplement 12Labeling	Approved	Letter Label
Oct 14, 2011	Supplement 11Labeling	Approved	Label Letter
Mar 20, 2011	Supplement 10Labeling	Approved	Letter Label
Sep 18, 2009	Supplement 7Labeling · Standard review	Approved	Letter Label
Oct 29, 2003	Supplement 3Labeling · Standard review	Approved	Letter
Jan 28, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 28, 1999	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20125
Drugs@FDA: Overview at FDA
Company: Pfizer Pharmaceuticals

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