APPLICATION
ANDA077004
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-07
LATEST ACTION
2019-12-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RAMIPRILDiscontinued
RAMIPRIL 5MG · CAPSULE · ORAL
RAMIPRILDiscontinued
RAMIPRIL 1.25MG · CAPSULE · ORAL
RAMIPRILDiscontinued
RAMIPRIL 10MG · CAPSULE · ORAL
RAMIPRILDiscontinued
RAMIPRIL 2.5MG · CAPSULE · ORAL
Approval history
2019-12-09Labeling · Supplement 4 · standardAP
2019-12-09Labeling · Supplement 2 · standardAP
2014-09-26Labeling · 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.