Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021664

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BROMDAY (BROMFENAC SODIUM)
EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: BROMFENAC SODIUM
Proprietary Name: BROMDAY
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021664
Product Number: 002
Approval Date: Oct 16, 2010
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

XIBROM (BROMFENAC SODIUM)
EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: BROMFENAC SODIUM
Proprietary Name: XIBROM
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021664
Product Number: 001
Approval Date: Mar 24, 2005
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information