APPLICATION
ANDA074265
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-28
LATEST ACTION
2000-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATENOLOLDiscontinued
ATENOLOL 100MG · TABLET · ORAL
ATENOLOLDiscontinued
ATENOLOL 25MG · TABLET · ORAL
ATENOLOLDiscontinued
ATENOLOL 50MG · TABLET · ORAL
Approval history
2000-01-27Manufacturing (CMC) · Supplement 14AP
2000-01-27Manufacturing (CMC) · Supplement 12AP
2000-01-27Manufacturing (CMC) · Supplement 15AP
2000-01-27Manufacturing (CMC) · Supplement 13AP
1997-10-21Manufacturing (CMC) · Supplement 10AP
1997-08-08Labeling · Supplement 11AP
1997-06-04Manufacturing (CMC) · Supplement 8AP
1997-04-01Labeling · Supplement 9AP
1996-03-13Manufacturing (CMC) · Supplement 7AP
1996-03-13Labeling · Supplement 5AP
1996-03-13Manufacturing (CMC) · Supplement 3AP
1996-03-13Manufacturing (CMC) · Supplement 6AP
1996-03-13Manufacturing (CMC) · Supplement 4AP
1994-09-02Labeling · Supplement 2AP
1994-08-01Labeling · Supplement 1AP
1994-02-28OriginalAP
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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