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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203168

PROLENSA (BROMFENAC SODIUM)
EQ 0.07% ACID
Marketing Status: Prescription
Active Ingredient: BROMFENAC SODIUM
Proprietary Name: PROLENSA
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 0.07% ACID
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203168
Product Number: 001
Approval Date: Apr 5, 2013
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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