← FDA DRUG APPROVALS

FDA ANDA · ANDA077470

RAMIPRIL

Sponsor: TEVA PHARMS

APPLICATION
ANDA077470
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-18
LATEST ACTION
2014-09-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

RAMIPRILDiscontinued
RAMIPRIL 10MG · CAPSULE · ORAL
RAMIPRILDiscontinued
RAMIPRIL 2.5MG · CAPSULE · ORAL
RAMIPRILDiscontinued
RAMIPRIL 5MG · CAPSULE · ORAL
RAMIPRILDiscontinued
RAMIPRIL 1.25MG · CAPSULE · ORAL

Approval history

2014-09-25Labeling · Supplement 10 · standardAP
2014-09-25Labeling · Supplement 9 · standardAP
2014-09-25Labeling · Supplement 7 · standardAP
2014-09-25Labeling · Supplement 8 · standardAP
2014-09-25Labeling · Supplement 6AP
2011-05-13Labeling · Supplement 5AP
2011-01-27Labeling · Supplement 4AP
2009-10-22Manufacturing (CMC) · Supplement 3AP
2008-06-18Original — 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 →