← FDA DRUG APPROVALS

FDA ANDA · ANDA076549

RAMIPRIL

Sponsor: WATSON LABS

APPLICATION
ANDA076549
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-24
LATEST ACTION
2020-10-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

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

Approval history

2020-10-23Labeling · Supplement 18 · standardAP
2015-12-21Labeling · Supplement 17 · standardAP
2015-12-21Labeling · Supplement 16 · standardAP
2014-09-25Labeling · Supplement 15 · standardAP
2013-01-17Labeling · Supplement 12 · standardAP
2013-01-17Labeling · Supplement 11AP
2013-01-17Labeling · Supplement 9AP
2010-09-10Labeling · Supplement 6AP
2005-10-24Original — 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 →