APPLICATION
ANDA205670
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-29
LATEST ACTION
2016-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 20MG · TABLET · ORAL
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 40MG · TABLET · ORAL
FOSINOPRIL SODIUMPrescription
FOSINOPRIL SODIUM 10MG · TABLET · ORAL
Approval history
2016-08-29UNKNOWN · Original · standardAP
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.