APPLICATION
ANDA076374
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-31
LATEST ACTION
2022-05-27
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
2022-05-27Labeling · Supplement 13 · standardAP
2022-05-27Labeling · Supplement 11 · standardAP
2022-05-27Labeling · Supplement 12 · standardAP
2019-11-06Labeling · Supplement 10 · standardAP
2016-02-11Labeling · Supplement 9 · standardAP
2016-02-11Labeling · Supplement 7AP
2016-02-11Labeling · Supplement 8 · standardAP
2004-09-23Labeling · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.