APPLICATION
ANDA073026
TYPE
ANDA
ORIGINAL APPROVAL
1991-09-17
LATEST ACTION
2023-08-29
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
2023-08-29Labeling · Supplement 48 · standardAP
2023-08-29Labeling · Supplement 46 · standardAP
2014-11-03Labeling · Supplement 41 · standardAP
2011-11-30Labeling · Supplement 40AP
2008-08-28Labeling · Supplement 39AP
2007-04-11Labeling · Supplement 36AP
2002-04-19Manufacturing (CMC) · Supplement 28AP
2002-03-22Labeling · Supplement 26AP
2002-03-22Manufacturing (CMC) · Supplement 24AP
2002-03-22Manufacturing (CMC) · Supplement 27AP
2002-03-22Manufacturing (CMC) · Supplement 25AP
2001-08-07Manufacturing (CMC) · Supplement 23AP
2001-06-08Manufacturing (CMC) · Supplement 22AP
2001-03-08Manufacturing (CMC) · Supplement 21AP
2000-07-24Labeling · Supplement 20AP
2000-03-29Labeling · Supplement 18AP
1999-05-05Manufacturing (CMC) · Supplement 17AP
1999-04-27Manufacturing (CMC) · Supplement 16AP
1999-04-27Manufacturing (CMC) · Supplement 15AP
1999-04-05Manufacturing (CMC) · Supplement 13AP
1999-04-05Labeling · Supplement 14AP
1997-10-01Manufacturing (CMC) · Supplement 12AP
1997-08-13Manufacturing (CMC) · Supplement 10AP
1997-02-26Labeling · Supplement 11AP
1996-03-01Labeling · Supplement 9AP
1995-03-22Labeling · Supplement 8AP
1994-01-24Manufacturing (CMC) · Supplement 7AP
1993-10-08Manufacturing (CMC) · Supplement 5AP
1993-09-08Labeling · Supplement 6AP
1993-07-12Manufacturing (CMC) · Supplement 4AP
1993-04-07Labeling · Supplement 3AP
1992-10-28Labeling · Supplement 2AP
1992-05-01Labeling · Supplement 1AP
1991-09-17OriginalAP
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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