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FDA NDA · NDA021571

IQUIX

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APPLICATION
NDA021571
TYPE
NDA
ORIGINAL APPROVAL
2004-03-01
LATEST ACTION
2014-12-03
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

IQUIX · ReferenceDiscontinued
LEVOFLOXACIN 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2014-12-03Labeling · Supplement 6 · standardLabelAP
2004-03-01Type 3 - New Dosage Form · Original · standardLabelAP
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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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