← FDA DRUG APPROVALS

FDA ANDA · ANDA078450

QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078450
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-24
LATEST ACTION
2022-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, QUINAPRIL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2022-05-26Labeling · Supplement 17 · standardAP
2022-05-26Labeling · Supplement 21 · standardAP
2022-05-26Labeling · Supplement 26 · standardAP
2022-05-26Labeling · Supplement 24 · standardAP
2016-02-16Labeling · Supplement 15 · standardAP
2015-04-26Labeling · Supplement 13 · standardAP
2014-11-26Labeling · Supplement 10 · standardAP
2014-11-26Labeling · Supplement 6AP
2014-11-26Labeling · Supplement 11 · standardAP
2014-11-26Labeling · Supplement 7 · standardAP
2014-11-26Labeling · Supplement 12 · standardAP
2011-11-28Labeling · Supplement 5AP
2011-08-02Labeling · Supplement 4AP
2010-07-30Labeling · Supplement 2AP
2007-08-24Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →