Quinapril Hydrochloride

ANDA 76803, held by Chartwell Rx. Quinapril Hydrochloride.

First approved: Mar 2, 2005
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 2, 2005	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Quinapril HydrochlorideEQ 5MG BASE · tablet;oral	Quinapril Hydrochloride	Rx
Quinapril HydrochlorideEQ 10MG BASE · tablet;oral	Quinapril Hydrochloride	Rx
Quinapril HydrochlorideEQ 20MG BASE · tablet;oral	Quinapril Hydrochloride	Rx
Quinapril HydrochlorideEQ 40MG BASE · tablet;oral	Quinapril Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 2, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Mar 2, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76803
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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