APPLICATION
ANDA076607
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-15
LATEST ACTION
2015-11-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2015-11-25Labeling · Supplement 13 · standardAP
2015-03-09Labeling · Supplement 11 · standardAP
2015-03-09Labeling · Supplement 9 · standardAP
2015-03-09Labeling · Supplement 12 · standardAP
2015-03-09Labeling · Supplement 10 · standardAP
2012-12-14Labeling · Supplement 8 · standardAP
2012-12-14Labeling · Supplement 7AP
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.