APPLICATION
ANDA072304
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-15
LATEST ACTION
2002-06-07
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
2002-06-07Manufacturing (CMC) · Supplement 25AP
2000-12-26Manufacturing (CMC) · Supplement 24AP
1999-08-02Manufacturing (CMC) · Supplement 23AP
1997-10-09Manufacturing (CMC) · Supplement 21AP
1997-01-29Labeling · Supplement 22AP
1995-05-25Manufacturing (CMC) · Supplement 20AP
1994-10-18Labeling · Supplement 19AP
1993-12-16Labeling · Supplement 18AP
1993-03-10Labeling · Supplement 17AP
1992-06-18Manufacturing (CMC) · Supplement 14AP
1992-06-18Manufacturing (CMC) · Supplement 15AP
1992-06-18Labeling · Supplement 16AP
1991-12-06Labeling · Supplement 13AP
1990-11-08Labeling · Supplement 12AP
1990-10-01Labeling · Supplement 11AP
1989-12-15Labeling · Supplement 10AP
1989-08-14Manufacturing (CMC) · Supplement 2AP
1989-08-14Manufacturing (CMC) · Supplement 5AP
1989-08-14Manufacturing (CMC) · Supplement 3AP
1989-08-14Labeling · Supplement 4AP
1989-03-29Manufacturing (CMC) · Supplement 1AP
1988-12-15Manufacturing (CMC) · Supplement 6AP
1988-07-15OriginalAP
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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