APPLICATION
ANDA076900
TYPE
ANDA
ORIGINAL APPROVAL
2005-01-28
LATEST ACTION
2024-03-28
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
2024-03-28Labeling · Supplement 31 · standardAP
2014-10-31Labeling · Supplement 24 · standardAP
2011-09-13Labeling · Supplement 23AP
2009-02-19Labeling · Supplement 11AP
2009-02-19Labeling · Supplement 9AP
2009-02-19Labeling · Supplement 12AP
2009-01-14Labeling · Supplement 18AP
2008-08-29Labeling · Supplement 17AP
2007-03-01Manufacturing (CMC) · Supplement 6AP
2007-01-27Manufacturing (CMC) · Supplement 3AP
2007-01-27Manufacturing (CMC) · Supplement 4AP
2006-07-17Labeling · Supplement 2AP
2005-01-28OriginalAP
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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