← FDA DRUG APPROVALS

FDA NDA · NDA211039

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Sponsor: BAUSCH LOMB IRELAND

APPLICATION
NDA211039
TYPE
NDA
ORIGINAL APPROVAL
2020-03-09
LATEST ACTION
2020-03-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE · ReferencePrescription
BENOXINATE HYDROCHLORIDE 0.4%, FLUORESCEIN SODIUM 0.3% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2020-03-09Type 4 - New Combination · Original · standard — Label ↗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.

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 →