← FDA DRUG APPROVALS
FDA ANDA · ANDA201356
QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5
Sponsor: INVAGEN PHARMS
APPLICATION
ANDA201356
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-20
LATEST ACTION
2022-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, QUINAPRIL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
Approval history
2022-05-25Labeling · Supplement 13 · standardAP
2019-11-06Labeling · Supplement 11 · standardAP
2015-11-24Labeling · Supplement 5 · standardAP
2015-06-30Labeling · Supplement 1 · standardAP
2015-06-30Labeling · Supplement 4 · standardAP
2015-06-30Labeling · Supplement 2 · standardAP
2011-04-20Not Applicable · OriginalAP
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.