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FDA NDA · NDA021114

BETAXON

Sponsor: ALCON PHARMS LTD

APPLICATION
NDA021114
TYPE
NDA
ORIGINAL APPROVAL
2000-02-23
LATEST ACTION
2010-03-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued

Products

BETAXONDiscontinued
LEVOBETAXOLOL HYDROCHLORIDE EQ 0.5% BASE · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2010-03-09Labeling · Supplement 3 · standard — Label ↗AP
2006-09-28Efficacy · Supplement 2 · priority — Pediatric Written Request ↗AP
2006-06-11Labeling · Supplement 11 · priorityAP
2000-02-23Type 2 - New Active Ingredient · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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