APPLICATION
ANDA073582
TYPE
ANDA
ORIGINAL APPROVAL
1993-04-29
LATEST ACTION
2015-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATENOLOL AND CHLORTHALIDONEDiscontinued
ATENOLOL 50MG, CHLORTHALIDONE 25MG · TABLET · ORAL
ATENOLOL AND CHLORTHALIDONEDiscontinued
ATENOLOL 100MG, CHLORTHALIDONE 25MG · TABLET · ORAL
Approval history
2015-06-30Labeling · Supplement 37 · standardAP
2015-06-30Labeling · Supplement 36AP
2010-03-15Labeling · Supplement 35AP
2005-08-30Labeling · Supplement 27AP
2005-08-30Labeling · Supplement 28AP
2002-12-06Manufacturing (CMC) · Supplement 17AP
2002-07-29Manufacturing (CMC) · Supplement 18AP
2001-02-20Manufacturing (CMC) · Supplement 16AP
2000-09-21Labeling · Supplement 15AP
2000-05-16Manufacturing (CMC) · Supplement 13AP
2000-05-16Manufacturing (CMC) · Supplement 14AP
1997-12-05Manufacturing (CMC) · Supplement 12AP
1997-05-14Labeling · Supplement 11AP
1997-02-24Manufacturing (CMC) · Supplement 10AP
1997-02-18Manufacturing (CMC) · Supplement 7AP
1996-11-29Labeling · Supplement 9AP
1996-09-25Manufacturing (CMC) · Supplement 8AP
1995-06-22Manufacturing (CMC) · Supplement 6AP
1995-02-15Labeling · Supplement 5AP
1994-09-16Labeling · Supplement 4AP
1994-05-23Labeling · Supplement 3AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1993-12-22Labeling · Supplement 2AP
1993-04-29OriginalAP
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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