← FDA DRUG APPROVALS

FDA NDA · NDA206307

XTORO

finafloxacin

Sponsor: FONSECA BIOSCIENCES

APPLICATION
NDA206307
TYPE
NDA
ORIGINAL APPROVAL
2014-12-17
LATEST ACTION
2026-03-18
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

XTORO · ReferencePrescription
FINAFLOXACIN 0.3% · SUSPENSION/DROPS · OTIC

Approval history

2026-03-18Labeling · Supplement 6 · standard — Letter ↗AP
2026-03-18Labeling · Supplement 4 · standard — Letter ↗AP
2015-12-29Manufacturing (CMC) · Supplement 1 · priorityAP
2014-12-17Type 1 - New Molecular Entity · Original · priority — Review ↗AP
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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