Accupril

NDA 19885, held by Pfizer Pharms. Quinapril Hydrochloride.

As of Nov 13, 2026, NDA 19885 (Accupril), held by Pfizer Pharms, was first approved by FDA on Nov 19, 1991, with 33 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1991
Review: Standard
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below


Oct 29, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Nov 19, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


AccuprilEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Quinapril Hydrochloride	DiscontinuedReference drug
AccuprilEQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Quinapril Hydrochloride	DiscontinuedReference drug
AccuprilEQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Quinapril Hydrochloride	DiscontinuedReference drug
AccuprilEQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Quinapril Hydrochloride	DiscontinuedReference drug

All 34 submissions, including labeling and manufacturing supplements


May 18, 2020	Supplement 45Labeling · Standard review	Approved	Label Letter
Apr 26, 2017	Supplement 43Labeling · Standard review	Approved	Letter Label
Feb 13, 2017	Supplement 42Labeling · Standard review	Approved	Label Letter
Sep 11, 2015	Supplement 41Labeling · Standard review	Approved	Letter Label
May 2, 2014	Supplement 40Labeling · Standard review	Approved	Letter Label
Oct 25, 2013	Supplement 39Labeling · Standard review	Approved	Label Letter
Sep 23, 2013	Supplement 38Labeling · Standard review	Approved	Letter Label
Apr 9, 2013	Supplement 37Labeling · Standard review	Approved	Label Letter
Sep 21, 2012	Supplement 36Labeling	Approved	Label
Jan 18, 2012	Supplement 35Labeling	Approved	Letter Label
Oct 14, 2011	Supplement 33Labeling	Approved	Label Letter
Sep 18, 2009	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 29, 2003	Supplement 23Labeling · Standard review	Approved	Letter
Dec 13, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 22, 2002	Supplement 19Labeling · Standard review	Approved	Letter
Jun 21, 2001	Supplement 20Labeling · Standard review	Approved	None posted
Apr 17, 2001	Supplement 18Labeling · Standard review	Approved	Letter
Sep 10, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
May 4, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 25, 1998	Supplement 15Labeling · Standard review	Approved	None posted
Jul 3, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 2, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 1, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 3, 1996	Supplement 11Labeling · Standard review	Approved	None posted
Jun 18, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 12, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Nov 20, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 2, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 12, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Oct 29, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
May 26, 1993	Supplement 4Labeling · Standard review	Approved	None posted
May 7, 1992	Supplement 2Labeling	Approved	None posted
Nov 19, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19885
Drugs@FDA: Overview at FDA
Company: Pfizer 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