APPLICATION
ANDA074099
TYPE
ANDA
ORIGINAL APPROVAL
1992-04-28
LATEST ACTION
2025-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATENOLOLDiscontinued
ATENOLOL 25MG · TABLET · ORAL
Approval history
2025-07-29Labeling · Supplement 30 · standardAP
2025-07-29Labeling · Supplement 31 · standardAP
2005-09-14Labeling · Supplement 21AP
2001-05-21Manufacturing (CMC) · Supplement 19AP
2000-06-05Labeling · Supplement 16AP
1999-05-24Manufacturing (CMC) · Supplement 15AP
1999-04-05Manufacturing (CMC) · Supplement 14AP
1999-03-12Manufacturing (CMC) · Supplement 13AP
1997-07-30Manufacturing (CMC) · Supplement 12AP
1997-07-30Manufacturing (CMC) · Supplement 11AP
1997-02-18Labeling · Supplement 10AP
1996-06-10Manufacturing (CMC) · Supplement 9AP
1996-05-15Manufacturing (CMC) · Supplement 8AP
1996-05-15Manufacturing (CMC) · Supplement 7AP
1994-10-04Manufacturing (CMC) · Supplement 5AP
1994-09-08Labeling · Supplement 6AP
1994-01-14Manufacturing (CMC) · Supplement 3AP
1993-12-13Labeling · Supplement 4AP
1993-02-04Labeling · Supplement 2AP
1992-09-25Labeling · Supplement 1AP
1992-04-28OriginalAP
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.
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