← FDA DRUG APPROVALS

FDA ANDA · ANDA078457

QUINAPRIL

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA078457
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-24
LATEST ACTION
2019-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
QUINAPRIL HYDROCHLORIDEDiscontinued
QUINAPRIL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL

Approval history

2019-11-06Labeling · Supplement 11 · standardAP
2015-11-25Labeling · Supplement 6 · standardAP
2015-11-25Labeling · Supplement 5 · standardAP
2012-12-17Labeling · Supplement 3 · standardAP
2010-01-28Labeling · 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 →