APPLICATION
ANDA074056
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-18
LATEST ACTION
2025-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATENOLOLPrescription
ATENOLOL 100MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 25MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 50MG · TABLET · ORAL
Approval history
2025-03-17Labeling · Supplement 51 · standardAP
2015-06-08Labeling · Supplement 38 · standardAP
2014-06-23Manufacturing (CMC) · Supplement 33AP
2011-10-25Labeling · Supplement 34AP
2008-10-21Labeling · Supplement 27AP
2005-12-12Labeling · Supplement 25AP
2004-07-19Labeling · Supplement 22AP
2004-05-25Labeling · Supplement 24AP
2001-09-10Manufacturing (CMC) · Supplement 20AP
2001-02-20Manufacturing (CMC) · Supplement 19AP
2001-02-20Manufacturing (CMC) · Supplement 18AP
2000-11-02Manufacturing (CMC) · Supplement 16AP
2000-11-02Manufacturing (CMC) · Supplement 14AP
2000-08-10Labeling · Supplement 17AP
2000-06-09Labeling · Supplement 15AP
2000-01-24Manufacturing (CMC) · Supplement 13AP
1999-12-02Manufacturing (CMC) · Supplement 12AP
1999-12-02Manufacturing (CMC) · Supplement 11AP
1999-02-12Manufacturing (CMC) · Supplement 6AP
1999-02-12Manufacturing (CMC) · Supplement 5AP
1997-08-01Manufacturing (CMC) · Supplement 4AP
1997-01-28Labeling · Supplement 3AP
1996-09-13Manufacturing (CMC) · Supplement 2AP
1996-08-16Manufacturing (CMC) · Supplement 1AP
1995-01-18OriginalAP
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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