APPLICATION
ANDA078512
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-31
LATEST ACTION
2024-03-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATENOLOLPrescription
ATENOLOL 50MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 100MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 25MG · TABLET · ORAL
Approval history
2024-03-29Labeling · Supplement 18 · standardAP
2015-05-27Labeling · Supplement 7 · standardAP
2012-01-17Manufacturing (CMC) · Supplement 4AP
2011-10-18Labeling · Supplement 5AP
2009-09-02Labeling · Supplement 2AP
2007-10-31OriginalAP
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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