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Quinapril Hydrochloride And Hydrochlorothiazide

ANDA 77093, held by Pharmobedient. Hydrochlorothiazide; Quinapril Hydrochloride.

  • First approved: Mar 28, 2005
  • Supplements approved: 10
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below
DateSubmissionStatusDocuments
Mar 28, 2005Original applicationApprovedNone posted

Products

3 strengths and forms
ProductActive ingredientMarketing
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 10MG BASE · tablet;oralHydrochlorothiazide; Quinapril HydrochlorideDiscontinued
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 20MG BASE · tablet;oralHydrochlorothiazide; Quinapril HydrochlorideDiscontinued
Quinapril Hydrochloride And Hydrochlorothiazide25MG;EQ 20MG BASE · tablet;oralHydrochlorothiazide; Quinapril HydrochlorideDiscontinued
All 11 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
May 26, 2022Supplement 18Labeling · Standard reviewApprovedNone posted
May 26, 2022Supplement 19Labeling · Standard reviewApprovedNone posted
May 26, 2022Supplement 20Labeling · Standard reviewApprovedNone posted
May 26, 2022Supplement 21Labeling · Standard reviewApprovedNone posted
Feb 16, 2016Supplement 15Labeling · Standard reviewApprovedNone posted
Apr 24, 2015Supplement 10Labeling · Standard reviewApprovedNone posted
Apr 24, 2015Supplement 11Labeling · Standard reviewApprovedNone posted
Apr 24, 2015Supplement 13Labeling · Standard reviewApprovedNone posted
Apr 24, 2015Supplement 14Labeling · Standard reviewApprovedNone posted
Jan 10, 2011Supplement 8LabelingApprovedNone posted
Mar 28, 2005Original applicationApprovedNone posted

Identifiers

Application
ANDA 77093

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

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