APPLICATION
ANDA073542
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-19
LATEST ACTION
2025-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATENOLOLDiscontinued
ATENOLOL 50MG · TABLET · ORAL
Approval history
2025-07-29Labeling · Supplement 30 · standardAP
2025-07-29Labeling · Supplement 29 · standardAP
2005-09-19Labeling · Supplement 20AP
2001-05-21Manufacturing (CMC) · Supplement 18AP
2000-06-05Labeling · Supplement 15AP
1999-05-24Manufacturing (CMC) · Supplement 14AP
1999-04-05Manufacturing (CMC) · Supplement 13AP
1999-03-12Manufacturing (CMC) · Supplement 12AP
1997-02-18Labeling · Supplement 11AP
1996-05-15Manufacturing (CMC) · Supplement 10AP
1996-05-15Manufacturing (CMC) · Supplement 9AP
1994-10-04Manufacturing (CMC) · Supplement 7AP
1994-09-08Labeling · Supplement 8AP
1994-05-17Manufacturing (CMC) · Supplement 4AP
1994-01-14Manufacturing (CMC) · Supplement 6AP
1993-12-13Labeling · Supplement 5AP
1993-02-04Labeling · Supplement 3AP
1992-09-25Labeling · Supplement 2AP
1992-04-22Labeling · Supplement 1AP
1991-12-19OriginalAP
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.
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