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FDA ANDA · ANDA074107

ATENOLOL AND CHLORTHALIDONE

Sponsor: PLIVA

APPLICATION
ANDA074107
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-24
LATEST ACTION
2001-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ATENOLOL AND CHLORTHALIDONEDiscontinued
ATENOLOL 100MG, CHLORTHALIDONE 25MG · TABLET · ORAL
ATENOLOL AND CHLORTHALIDONEDiscontinued
ATENOLOL 50MG, CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

2001-04-18Labeling · Supplement 3AP
2000-07-07Manufacturing (CMC) · Supplement 2AP
1998-06-22Manufacturing (CMC) · Supplement 1AP
1997-09-24OriginalAP
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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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