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FDA NDA · NDA019807

KERLEDEX

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA019807
TYPE
NDA
ORIGINAL APPROVAL
1992-10-30
LATEST ACTION
2011-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

KERLEDEXDiscontinued
BETAXOLOL HYDROCHLORIDE 5MG, CHLORTHALIDONE 12.5MG · TABLET · ORAL
KERLEDEXDiscontinued
BETAXOLOL HYDROCHLORIDE 10MG, CHLORTHALIDONE 12.5MG · TABLET · ORAL

Approval history

2011-08-20Labeling · Supplement 2 · standard — Label ↗AP
2011-03-20Labeling · Supplement 1 · standard — Letter ↗AP
1992-10-30Type 4 - New Combination · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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