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Quinapril Hydrochloride And Hydrochlorothiazide

ANDA 76374, held by Chartwell Rx. Hydrochlorothiazide; Quinapril Hydrochloride.

  • First approved: Mar 31, 2004
  • Supplements approved: 8
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below
DateSubmissionStatusDocuments
Mar 31, 2004Original applicationApprovedLetter

Products

3 strengths and forms
ProductActive ingredientMarketing
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 10MG BASE · tablet;oralHydrochlorothiazide; Quinapril HydrochlorideRx
Quinapril Hydrochloride And Hydrochlorothiazide12.5MG;EQ 20MG BASE · tablet;oralHydrochlorothiazide; Quinapril HydrochlorideRx
Quinapril Hydrochloride And Hydrochlorothiazide25MG;EQ 20MG BASE · tablet;oralHydrochlorothiazide; Quinapril HydrochlorideRx
All 9 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
May 27, 2022Supplement 11Labeling · Standard reviewApprovedNone posted
May 27, 2022Supplement 12Labeling · Standard reviewApprovedNone posted
May 27, 2022Supplement 13Labeling · Standard reviewApprovedNone posted
Nov 6, 2019Supplement 10Labeling · Standard reviewApprovedNone posted
Feb 11, 2016Supplement 7LabelingApprovedNone posted
Feb 11, 2016Supplement 8Labeling · Standard reviewApprovedNone posted
Feb 11, 2016Supplement 9Labeling · Standard reviewApprovedNone posted
Sep 23, 2004Supplement 1LabelingApprovedNone posted
Mar 31, 2004Original applicationApprovedLetter

Identifiers

Application
ANDA 76374

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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