← FDA DRUG APPROVALS

FDA NDA · NDA019507

KERLONE

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA019507
TYPE
NDA
ORIGINAL APPROVAL
1989-10-27
LATEST ACTION
2011-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

KERLONEDiscontinued
BETAXOLOL HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
KERLONEDiscontinued
BETAXOLOL HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-08-17Labeling · Supplement 8 · standard — Letter ↗AP
2009-05-12Labeling · Supplement 7 · standard — Letter ↗AP
2008-08-06Labeling · Supplement 6 · standard — Letter ↗AP
1995-01-27Manufacturing (CMC) · Supplement 5 · standardAP
1992-06-01Labeling · Supplement 4 · standardAP
1990-10-26Manufacturing (CMC) · Supplement 2 · standardAP
1990-07-05Labeling · Supplement 1 · standardAP
1989-10-27Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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