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FDA NDA · NDA203168

BROMFENAC OPHTHALMIC SOLUTION

bromfenac sodium

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA203168
TYPE
NDA
ORIGINAL APPROVAL
2013-04-05
LATEST ACTION
2025-02-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

PROLENSA · ReferencePrescription
BROMFENAC SODIUM EQ 0.07% ACID · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-02-18Labeling · Supplement 5 · standard — Label ↗AP
2015-12-02Manufacturing (CMC) · Supplement 3 · standardAP
2015-07-01Manufacturing (CMC) · Supplement 1 · standardAP
2013-04-05Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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