← FDA DRUG APPROVALS

FDA ANDA · ANDA091163

FOSINOPRIL SODIUM

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA091163
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-30
LATEST ACTION
2013-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 40MG · TABLET · ORAL
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 10MG · TABLET · ORAL
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 20MG · TABLET · ORAL

Approval history

2013-12-31Labeling · Supplement 4 · standardAP
2011-03-30OriginalAP
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 →