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FDA NDA · NDA022428

MOXEZA

Sponsor: HARROW EYE

APPLICATION
NDA022428
TYPE
NDA
ORIGINAL APPROVAL
2010-11-19
LATEST ACTION
2021-08-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

MOXEZA · ReferenceDiscontinued
MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-08-11Labeling · Supplement 10 · standard — Label ↗AP
2017-02-17Labeling · Supplement 9 · standard — Label ↗AP
2012-09-14Labeling · Supplement 2 · standard — Label ↗AP
2011-10-18Labeling · Supplement 1 · standard — Letter ↗AP
2010-11-19Type 3 - New Dosage Form · Original · standard — Label ↗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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