APPLICATION
ANDA077443
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-13
LATEST ACTION
2025-07-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATENOLOLPrescription
ATENOLOL 50MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 100MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 25MG · TABLET · ORAL
Approval history
2025-07-30Labeling · Supplement 16 · standardAP
2014-11-04Labeling · Supplement 5 · standardAP
2011-11-28Labeling · Supplement 3AP
2010-07-06Labeling · Supplement 2AP
2006-09-13OriginalAP
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.