← FDA DRUG APPROVALS

FDA ANDA · ANDA076407

OFLOXACIN

Sponsor: SENTISS

APPLICATION
ANDA076407
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-15
LATEST ACTION
2020-07-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

OFLOXACINPrescription
OFLOXACIN 0.3% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2020-07-15Labeling · Supplement 3 · standardAP
2008-04-15OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →