← FDA DRUG APPROVALS

FDA NDA · NDA021598

VIGAMOX

moxifloxacin hydrochloride

Sponsor: HARROW EYE

APPLICATION
NDA021598
TYPE
NDA
ORIGINAL APPROVAL
2003-04-15
LATEST ACTION
2020-06-02
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

VIGAMOX · ReferencePrescription
MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2020-06-02Labeling · Supplement 24 · standard — Letter ↗AP
2020-05-11Labeling · Supplement 23 · standard — Label ↗AP
2017-03-14Labeling · Supplement 22 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 17 · unknown — Letter ↗AP
2004-06-25Labeling · Supplement 8 · standard — Label ↗AP
2004-04-12Labeling · Supplement 2 · standard — Label ↗AP
2003-10-03Labeling · Supplement 5 · standard — Letter ↗AP
2003-10-03Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2003-04-15Type 3 - New Dosage Form · Original · standard — 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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