Quinapril Hydrochloride And Hydrochlorothiazide

ANDA 201356, held by Invagen Pharms. Hydrochlorothiazide; Quinapril Hydrochloride.

First approved: Apr 20, 2011
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 20, 2011	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 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 25, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Nov 6, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Nov 24, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Apr 20, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201356
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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