← FDA DRUG APPROVALS

FDA NDA · NDA021664

BROMDAY

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA021664
TYPE
NDA
ORIGINAL APPROVAL
2005-03-24
LATEST ACTION
2014-12-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

BROMDAY · ReferenceDiscontinued
BROMFENAC SODIUM EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
XIBROM · ReferenceDiscontinued
BROMFENAC SODIUM EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2014-12-11Manufacturing (CMC) · Supplement 20 · standardAP
2014-01-27Labeling · Supplement 14 · unknown — Letter ↗AP
2014-01-27Labeling · Supplement 19 · standard — Letter ↗AP
2010-10-16Efficacy · Supplement 13 · standard — Label ↗AP
2009-06-02Labeling · Supplement 10 · standard — Label ↗AP
2006-01-27Efficacy · Supplement 1 · unknown — Label ↗AP
2005-03-24Type 3 - New Dosage Form · Original · standard — 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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