APPLICATION
ANDA073315
TYPE
ANDA
ORIGINAL APPROVAL
1993-05-28
LATEST ACTION
2000-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATENOLOLDiscontinued
ATENOLOL 50MG · TABLET · ORAL
Approval history
2000-02-16Labeling · Supplement 7AP
1998-05-13Manufacturing (CMC) · Supplement 5AP
1996-11-01Labeling · Supplement 4AP
1995-05-30Manufacturing (CMC) · Supplement 3AP
1994-12-30Labeling · Supplement 2AP
1993-09-08Labeling · Supplement 1AP
1993-05-28OriginalAP
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.