APPLICATION
ANDA073353
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-27
LATEST ACTION
2006-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATENOLOLDiscontinued
ATENOLOL 100MG · TABLET · ORAL
Approval history
2006-12-13Labeling · Supplement 26AP
2006-06-22Labeling · Supplement 25AP
2003-09-25Labeling · Supplement 22AP
2001-04-25Manufacturing (CMC) · Supplement 18AP
2001-03-30Labeling · Supplement 19AP
2000-08-07Labeling · Supplement 17AP
1997-12-15Manufacturing (CMC) · Supplement 13AP
1997-12-15Manufacturing (CMC) · Supplement 14AP
1997-06-23Manufacturing (CMC) · Supplement 12AP
1996-11-25Labeling · Supplement 11AP
1994-11-08Labeling · Supplement 10AP
1994-03-31Labeling · Supplement 9AP
1993-07-22Manufacturing (CMC) · Supplement 7AP
1993-05-05Labeling · Supplement 6AP
1992-12-07Labeling · Supplement 3AP
1992-07-22Manufacturing (CMC) · Supplement 1AP
1992-07-06Labeling · Supplement 2AP
1991-12-27OriginalAP
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.