APPLICATION
ANDA073457
TYPE
ANDA
ORIGINAL APPROVAL
1992-01-24
LATEST ACTION
2024-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATENOLOLPrescription
ATENOLOL 25MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 50MG · TABLET · ORAL
ATENOLOLPrescription
ATENOLOL 100MG · TABLET · ORAL
Approval history
2024-09-18Labeling · Supplement 47 · standardAP
2015-07-01Labeling · Supplement 35 · standardAP
2005-12-12Labeling · Supplement 26AP
2004-02-06Labeling · Supplement 24AP
2003-10-28Labeling · Supplement 23AP
2003-01-03Manufacturing (CMC) · Supplement 21AP
2001-02-15Manufacturing (CMC) · Supplement 20AP
2000-08-10Labeling · Supplement 19AP
2000-06-07Labeling · Supplement 18AP
1999-04-26Manufacturing (CMC) · Supplement 14AP
1999-04-26Manufacturing (CMC) · Supplement 12AP
1999-04-26Labeling · Supplement 15AP
1999-04-26Manufacturing (CMC) · Supplement 13AP
1999-04-05Manufacturing (CMC) · Supplement 17AP
1999-02-25Labeling · Supplement 16AP
1998-08-14Manufacturing (CMC) · Supplement 11AP
1998-02-05Manufacturing (CMC) · Supplement 10AP
1997-02-13Labeling · Supplement 9AP
1996-10-30Manufacturing (CMC) · Supplement 8AP
1994-08-29Labeling · Supplement 7AP
1993-08-31Labeling · Supplement 6AP
1993-02-08Labeling · Supplement 4AP
1992-12-21Labeling · Supplement 3AP
1992-10-05Labeling · Supplement 2AP
1992-05-20Labeling · Supplement 1AP
1992-01-24OriginalAP
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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