← FDA DRUG APPROVALS

FDA NDA · NDA206911

BROMSITE 0.075%

bromfenac

Sponsor: SUN PHARM

APPLICATION
NDA206911
TYPE
NDA
ORIGINAL APPROVAL
2016-04-08
LATEST ACTION
2023-03-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

BROMSITE · ReferencePrescription
BROMFENAC SODIUM EQ 0.075% ACID · SOLUTION/DROPS · OPHTHALMIC

Approval history

2023-03-09Labeling · Supplement 8 · standard — Letter ↗AP
2016-04-08Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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