APPLICATION
ANDA072302
TYPE
ANDA
ORIGINAL APPROVAL
1990-05-31
LATEST ACTION
2001-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATENOLOL AND CHLORTHALIDONEPrescription
ATENOLOL 100MG, CHLORTHALIDONE 25MG · TABLET · ORAL
ATENOLOL AND CHLORTHALIDONEPrescription
ATENOLOL 50MG, CHLORTHALIDONE 25MG · TABLET · ORAL
Approval history
2001-01-08Manufacturing (CMC) · Supplement 12AP
1999-06-15Manufacturing (CMC) · Supplement 10AP
1999-06-15Manufacturing (CMC) · Supplement 11AP
1997-01-16Labeling · Supplement 9AP
1996-07-12Manufacturing (CMC) · Supplement 8AP
1995-06-19Manufacturing (CMC) · Supplement 7AP
1994-05-20Labeling · Supplement 6AP
1993-10-22Labeling · Supplement 5AP
1993-04-07Labeling · Supplement 4AP
1992-03-03Labeling · Supplement 3AP
1991-11-29Manufacturing (CMC) · Supplement 1AP
1991-04-30Manufacturing (CMC) · Supplement 2AP
1990-05-31OriginalAP
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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